Entrectinib (2) – Rozlytrek®

Solid tumours, neurotrophic tyrosine receptor kinase (NTRK) gene fusion, histology independent

Characteristics

Start date 01.09.2020 – Marketing authorisation: 31.07.2020
Resolution 18.02.2021
INN Entrectinib
Brand name Rozlytrek®
Pharm. company Roche Pharma AG
G-BA Procedure ID D-559
ATC code L01EX14 Other protein kinase inhibitors (L01EX)
ICD-10 codes (AIS) C00.0Malignant neoplasm of lipstick area of upper lip, C00.1Malignant neoplasm of lower lip NOS, C00.2Malignant neoplasm of vermilion border of lip NOS, C00.3Malignant neoplasm of buccal aspect of upper lip, C00.4Malignant neoplasm of buccal aspect of lower lip, C00.5Malignant neoplasm of buccal aspect of lip, unspecified, C00.6Malignant neoplasm of commissure of lip, unspecified, C00.8Malignant neoplasm of overlapping sites of lip, C00.9Malignant neoplasm of lip, unspecified, C01Malignant neoplasm of base of tongue, C02.0Malignant neoplasm of dorsal surface of tongue, C02.1Malignant neoplasm of tip of tongue, C02.2Malignant neoplasm of anterior two-thirds of tongue, ventral surface, C02.3Malignant neoplasm of middle third of tongue NOS, C02.4Malignant neoplasm of lingual tonsil, C02.8Malignant neoplasm of two or more contiguous sites of tongue, C02.9Malignant neoplasm of tongue, unspecified, C03.0Malignant neoplasm of upper gum, C03.1Malignant neoplasm of lower gum, C03.9Malignant neoplasm of gum, unspecified, C04.0Malignant neoplasm of anterior to the premolar-canine junction, C04.1Malignant neoplasm of lateral floor of mouth, C04.8Malignant neoplasm of overlapping sites of floor of mouth, C04.9Malignant neoplasm of floor of mouth, unspecified, C05.0Malignant neoplasm of hard palate, C05.1Malignant neoplasm of soft palate, C05.2Malignant neoplasm of uvula, C05.8Malignant neoplasm of overlapping sites of palate, C05.9Malignant neoplasm of roof of mouth, C06.0Malignant neoplasm of buccal mucosa NOS, C06.1Malignant neoplasm of buccal sulcus (upper) (lower), C06.2Malignant neoplasm of retromolar area, C06.8Malignant neoplasm of overlapping sites of other and unspecified parts of mouth, C06.9Malignant neoplasm of minor salivary gland, unspecified site, C07Malignant neoplasm of parotid gland, C08.0Malignant neoplasm of submaxillary gland, C08.1Malignant neoplasm of sublingual gland, C08.8, C08.9Malignant neoplasm of salivary gland (major) NOS, C09.0Malignant neoplasm of tonsillar fossa, C09.1Malignant neoplasm of tonsillar pillar (anterior) (posterior), C09.8Malignant neoplasm of overlapping sites of tonsil, C09.9Malignant neoplasm of tonsil NOS, C10.0Malignant neoplasm of vallecula, C10.1Malignant neoplasm of anterior surface of epiglottis, C10.2Malignant neoplasm of lateral wall of oropharynx, C10.3Malignant neoplasm of posterior wall of oropharynx, C10.4Malignant neoplasm of branchial cyst [site of neoplasm], C10.8Malignant neoplasm of junctional region of oropharynx, C10.9Malignant neoplasm of oropharynx, unspecified, C11.0Malignant neoplasm of roof of nasopharynx, C11.1Malignant neoplasm of adenoid, C11.2Malignant neoplasm of fossa of Rosenmüller, C11.3Malignant neoplasm of floor of nasopharynx, C11.8Malignant neoplasm of overlapping sites of nasopharynx, C11.9Malignant neoplasm of nasopharyngeal wall NOS, C12Malignant neoplasm of pyriform sinus, C13.0Malignant neoplasm of postcricoid region, C13.1Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, C13.2Malignant neoplasm of posterior wall of hypopharynx, C13.8Malignant neoplasm of overlapping sites of hypopharynx, C13.9Malignant neoplasm of hypopharyngeal wall NOS, C14.0Malignant neoplasm of pharynx, unspecified, C14.2Malignant neoplasm of Waldeyer´s ring, C14.8Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx, C15.0, C15.1, C15.2, C15.3Malignant neoplasm of upper third of esophagus, C15.4Malignant neoplasm of middle third of esophagus, C15.5Malignant neoplasm of lower third of esophagus, C15.8Malignant neoplasm of overlapping sites of esophagus, C15.9Malignant neoplasm of esophagus, unspecified, C16.0Malignant neoplasm of cardiac orifice, C16.1Malignant neoplasm of fundus of stomach, C16.2Malignant neoplasm of body of stomach, C16.3Malignant neoplasm of gastric antrum, C16.4Malignant neoplasm of prepylorus, C16.5Malignant neoplasm of lesser curvature of stomach, not classifiable to C16.1-C16.4, C16.6Malignant neoplasm of greater curvature of stomach, not classifiable to C16.0-C16.4, C16.8Malignant neoplasm of overlapping sites of stomach, C16.9Gastric cancer NOS, C17.0Malignant neoplasm of duodenum, C17.1Malignant neoplasm of jejunum, C17.2Malignant neoplasm of ileum, C17.3Meckel´s diverticulum, malignant, C17.8Malignant neoplasm of overlapping sites of small intestine, C17.9Malignant neoplasm of small intestine, unspecified, C18.0Malignant neoplasm of ileocecal valve, C18.1Malignant neoplasm of appendix, C18.2Malignant neoplasm of ascending colon, C18.3Malignant neoplasm of hepatic flexure, C18.4Malignant neoplasm of transverse colon, C18.5Malignant neoplasm of splenic flexure, C18.6Malignant neoplasm of descending colon, C18.7Malignant neoplasm of sigmoid colon, C18.8Malignant neoplasm of overlapping sites of colon, C18.9Malignant neoplasm of large intestine NOS, C19Malignant neoplasm of rectosigmoid junction, C20Malignant neoplasm of rectum, C21.0Malignant neoplasm of anus, unspecified, C21.1Malignant neoplasm of anal sphincter, C21.2Malignant neoplasm of cloacogenic zone, C21.8Malignant neoplasm of anorectal junction, C22.0Hepatocellular carcinoma, C22.1Intrahepatic bile duct carcinoma, C22.2Hepatoblastoma, C22.3Kupffer cell sarcoma, C22.4Other sarcomas of liver, C22.7Other specified carcinomas of liver, C22.9Malignant neoplasm of liver, not specified as primary or secondary, C23Malignant neoplasm of gallbladder, C24.0Malignant neoplasm of biliary duct or passage NOS, C24.1Malignant neoplasm of ampulla of Vater, C24.8Malignant neoplasm involving both intrahepatic and extrahepatic bile ducts, C24.9Malignant neoplasm of biliary tract, unspecified, C25.0Malignant neoplasm of head of pancreas, C25.1Malignant neoplasm of body of pancreas, C25.2Malignant neoplasm of tail of pancreas, C25.3Malignant neoplasm of pancreatic duct, C25.4Malignant neoplasm of islets of Langerhans, C25.7Malignant neoplasm of neck of pancreas, C25.8Malignant neoplasm of overlapping sites of pancreas, C25.9Malignant neoplasm of pancreas, unspecified, C26.0Malignant neoplasm of intestine NOS, C26.1Malignant neoplasm of spleen, C26.8, C26.9Malignant neoplasm of ill-defined sites within the digestive system, C30.0Malignant neoplasm of nasal cavity, C30.1Malignant neoplasm of middle ear, C31.0Malignant neoplasm of antrum (Highmore) (maxillary), C31.1Malignant neoplasm of ethmoidal sinus, C31.2Malignant neoplasm of frontal sinus, C31.3Malignant neoplasm of sphenoid sinus, C31.8Malignant neoplasm of overlapping sites of accessory sinuses, C31.9Malignant neoplasm of accessory sinus, unspecified, C32.0Malignant neoplasm of intrinsic larynx, C32.1Malignant neoplasm of supraglottis, C32.2Malignant neoplasm of subglottis, C32.3Malignant neoplasm of laryngeal cartilage, C32.8Malignant neoplasm of overlapping sites of larynx, C32.9Malignant neoplasm of larynx, unspecified, C33Malignant neoplasm of trachea, C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung, C37Malignant neoplasm of thymus, C38.0Malignant neoplasm of heart, C38.1Malignant neoplasm of anterior mediastinum, C38.2Malignant neoplasm of posterior mediastinum, C38.3Malignant neoplasm of mediastinum, part unspecified, C38.4Malignant neoplasm of pleura, C38.8Malignant neoplasm of overlapping sites of heart, mediastinum and pleura, C39.0Malignant neoplasm of upper respiratory tract, part unspecified, C39.8, C39.9Malignant neoplasm of respiratory tract NOS, C40.0Malignant neoplasm of scapula and long bones of upper limb, C40.1Malignant neoplasm of short bones of upper limb, C40.2Malignant neoplasm of long bones of lower limb, C40.3Malignant neoplasm of short bones of lower limb, C40.8Malignant neoplasm of overlapping sites of bone and articular cartilage of limb, C40.9Malignant neoplasm of unspecified bones and articular cartilage of limb, C41.01, C41.02, C41.1Malignant neoplasm of mandible, C41.2Malignant neoplasm of vertebral column, C41.30, C41.31, C41.32, C41.4Malignant neoplasm of pelvic bones, sacrum and coccyx, C41.8, C41.9Malignant neoplasm of bone and articular cartilage, unspecified, C43.0Malignant melanoma of lip, C43.1Malignant melanoma of eyelid, including canthus, C43.2Malignant melanoma of ear and external auricular canal, C43.3Malignant melanoma of other and unspecified parts of face, C43.4Malignant melanoma of scalp and neck, C43.5Malignant melanoma of trunk, C43.6Malignant melanoma of upper limb, including shoulder, C43.7Malignant melanoma of lower limb, including hip, C43.8Malignant melanoma of overlapping sites of skin, C43.9Malignant melanoma of unspecified site of skin, C44.0Other and unspecified malignant neoplasm of skin of lip, C44.1Other and unspecified malignant neoplasm of skin of eyelid, including canthus, C44.2Other and unspecified malignant neoplasm of skin of ear and external auricular canal, C44.3Other and unspecified malignant neoplasm of skin of other and unspecified parts of face, C44.4Other and unspecified malignant neoplasm of skin of scalp and neck, C44.5Other and unspecified malignant neoplasm of skin of trunk, C44.6Other and unspecified malignant neoplasm of skin of upper limb, including shoulder, C44.7Other and unspecified malignant neoplasm of skin of lower limb, including hip, C44.8Other and unspecified malignant neoplasm of overlapping sites of skin, C44.9Other and unspecified malignant neoplasm of skin, unspecified, C45.0Mesothelioma of pleura, C45.1Mesothelioma of peritoneum, C45.2Mesothelioma of pericardium, C45.7Mesothelioma of other sites, C45.9Mesothelioma, unspecified, C46.0Kaposi´s sarcoma of skin, C46.1Kaposi´s sarcoma of soft tissue, C46.2Kaposi´s sarcoma of palate, C46.3Kaposi´s sarcoma of lymph nodes, C46.7Kaposi´s sarcoma of other sites, C46.8, C46.9Kaposi´s sarcoma of unspecified site, C47.0Malignant neoplasm of peripheral nerves of head, face and neck, C47.1Malignant neoplasm of peripheral nerves of upper limb, including shoulder, C47.2Malignant neoplasm of peripheral nerves of lower limb, including hip, C47.3Malignant neoplasm of peripheral nerves of thorax, C47.4Malignant neoplasm of peripheral nerves of abdomen, C47.5Malignant neoplasm of peripheral nerves of pelvis, C47.6Malignant neoplasm of peripheral nerves of unspecified part of trunk, C47.8Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system, C47.9Malignant neoplasm of unspecified site of peripheral nerves and autonomic nervous system, C48.0Malignant neoplasm of retroperitoneum, C48.1Malignant neoplasm of cul-de-sac, C48.2Malignant neoplasm of peritoneum, unspecified, C48.8Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum, C49.0Malignant neoplasm of connective and soft tissue of head, face and neck, C49.1Malignant neoplasm of connective and soft tissue of upper limb, including shoulder, C49.2Malignant neoplasm of connective and soft tissue of lower limb, including hip, C49.3Malignant neoplasm of connective and soft tissue of thorax, C49.4Malignant neoplasm of abdominal wall, C49.5Malignant neoplasm of buttock, C49.6Malignant neoplasm of back NOS, C49.8Primary malignant neoplasm of two or more contiguous sites of connective and soft tissue, C49.9Malignant neoplasm of connective and soft tissue, unspecified, C50.0Malignant neoplasm of nipple and areola, C50.1Malignant neoplasm of central portion of breast, C50.2Malignant neoplasm of upper-inner quadrant of breast, C50.3Malignant neoplasm of lower-inner quadrant of breast, C50.4Malignant neoplasm of upper-outer quadrant of breast, C50.5Malignant neoplasm of lower-outer quadrant of breast, C50.6Malignant neoplasm of axillary tail of breast, C50.8Malignant neoplasm of overlapping sites of breast, C50.9Malignant neoplasm of breast of unspecified site, C51.0Malignant neoplasm of Bartholin´s [greater vestibular] gland, C51.1Malignant neoplasm of labium minus, C51.2Malignant neoplasm of clitoris, C51.8Malignant neoplasm of overlapping sites of vulva, C51.9Malignant neoplasm of external female genitalia NOS, C52Malignant neoplasm of vagina, C53.0Malignant neoplasm of endocervix, C53.1Malignant neoplasm of exocervix, C53.8Malignant neoplasm of overlapping sites of cervix uteri, C53.9Malignant neoplasm of cervix uteri, unspecified, C54.0Malignant neoplasm of lower uterine segment, C54.1Malignant neoplasm of endometrium, C54.2Malignant neoplasm of myometrium, C54.3Malignant neoplasm of fundus uteri, C54.8Malignant neoplasm of overlapping sites of corpus uteri, C54.9Malignant neoplasm of corpus uteri, unspecified, C55Malignant neoplasm of uterus, part unspecified, C56Malignant neoplasm of ovary, C57.0Malignant neoplasm of oviduct, C57.1Malignant neoplasm of broad ligament, C57.2Malignant neoplasm of round ligament, C57.3Malignant neoplasm of uterine ligament NOS, C57.4Malignant neoplasm of uterine adnexa, unspecified, C57.7Malignant neoplasm of wolffian body or duct, C57.8Primary malignant neoplasm of two or more contiguous sites of the female genital organs whose point of origin cannot be determined, C57.9Malignant neoplasm of female genitourinary tract NOS, C58Malignant neoplasm of placenta, C60.0Malignant neoplasm of foreskin, C60.1Malignant neoplasm of glans penis, C60.2Malignant neoplasm of corpus cavernosum, C60.8Malignant neoplasm of overlapping sites of penis, C60.9Malignant neoplasm of skin of penis NOS, C61Malignant neoplasm of prostate, C62.0Malignant neoplasm of ectopic testis, C62.1Malignant neoplasm of scrotal testis, C62.9Malignant neoplasm of testis, unspecified whether descended or undescended, C63.0Malignant neoplasm of epididymis, C63.1Malignant neoplasm of spermatic cord, C63.2Malignant neoplasm of skin of scrotum, C63.7Malignant neoplasm of seminal vesicle, C63.8Primary malignant neoplasm of two or more contiguous sites of male genital organs whose point of origin cannot be determined, C63.9Malignant neoplasm of male genitourinary tract NOS, C64Malignant neoplasm of kidney, except renal pelvis, C65Malignant neoplasm of renal pelvis, C66Malignant neoplasm of ureter, C67.0Malignant neoplasm of trigone of bladder, C67.1Malignant neoplasm of dome of bladder, C67.2Malignant neoplasm of lateral wall of bladder, C67.3Malignant neoplasm of anterior wall of bladder, C67.4Malignant neoplasm of posterior wall of bladder, C67.5Malignant neoplasm of internal urethral orifice, C67.6Malignant neoplasm of ureteric orifice, C67.7Malignant neoplasm of urachus, C67.8Malignant neoplasm of overlapping sites of bladder, C67.9Malignant neoplasm of bladder, unspecified, C68.0Malignant neoplasm of urethra, C68.1Malignant neoplasm of paraurethral glands, C68.8Primary malignant neoplasm of two or more contiguous sites of urinary organs whose point of origin cannot be determined, C68.9Malignant neoplasm of urinary system NOS, C69.0Malignant neoplasm of conjunctiva, C69.1Malignant neoplasm of cornea, C69.2Malignant neoplasm of retina, C69.3Malignant neoplasm of choroid, C69.4Malignant neoplasm of ciliary body, C69.5Malignant neoplasm of lacrimal sac, C69.6Malignant neoplasm of orbit, C69.8Malignant neoplasm of overlapping sites of eye and adnexa, C69.9Malignant neoplasm of eyeball, C70.0Malignant neoplasm of cerebral meninges, C70.1Malignant neoplasm of spinal meninges, C70.9Malignant neoplasm of meninges, unspecified, C71.0Malignant neoplasm of supratentorial NOS, C71.1Malignant neoplasm of frontal lobe, C71.2Malignant neoplasm of temporal lobe, C71.3Malignant neoplasm of parietal lobe, C71.4Malignant neoplasm of occipital lobe, C71.5Malignant neoplasm of cerebral ventricle, C71.6Malignant neoplasm of cerebellum, C71.7Malignant neoplasm of fourth cerebral ventricle, C71.8Malignant neoplasm of overlapping sites of brain, C71.9Malignant neoplasm of brain, unspecified, C72.0Malignant neoplasm of spinal cord, C72.1Malignant neoplasm of cauda equina, C72.2Malignant neoplasm of olfactory bulb, C72.3Malignant neoplasm of optic nerve, C72.4Malignant neoplasm of acoustic nerve, C72.5Malignant neoplasm of other and unspecified cranial nerves, C72.8, C72.9Malignant neoplasm of unspecified site of central nervous system, C73Malignant neoplasm of thyroid gland, C74.0Malignant neoplasm of cortex of adrenal gland, C74.1Malignant neoplasm of medulla of adrenal gland, C74.9Malignant neoplasm of unspecified part of adrenal gland, C75.0Malignant neoplasm of parathyroid gland, C75.1Malignant neoplasm of pituitary gland, C75.2Malignant neoplasm of craniopharyngeal duct, C75.3Malignant neoplasm of pineal gland, C75.4Malignant neoplasm of carotid body, C75.5Malignant neoplasm of aortic body and other paraganglia, C75.8Malignant neoplasm with pluriglandular involvement, unspecified, C75.9Malignant neoplasm of endocrine gland, unspecified, C76.0Malignant neoplasm of cheek NOS, C76.1Intrathoracic malignant neoplasm NOS, C76.2Malignant neoplasm of abdomen, C76.3Malignant neoplasm of groin NOS, C76.4Malignant neoplasm of upper limb, C76.5Malignant neoplasm of lower limb, C76.7, C76.8Malignant neoplasm of overlapping ill-defined sites, C80.0Carcinomatosis NOS, C80.9 Show more >>
Alpha-ID codes (AIS) I100412Malignant paraganglioma of the glomus aorticum, I102047Malignant neoplasm of the external auditory canal, I102091Malignant neoplasm of the ciliary body, I102097Malignant neoplasm of the cerebellum, I102104Malignant neoplasm of the upper respiratory tract, I102110Malignant neoplasm of the connective tissue of the upper extremity n.c, I102135Malignant neoplasm of the anterior part of the tongue n.c, I102140Malignant neoplasm of the connective tissue of the lower extremity n.c, I102158Malignant neoplasm of the cervix uteri, I102260Malignant neoplasm of the respiratory system n.c, I102269Malignant neoplasm of the transition of the cervix uteri to the vagina, I102271Malignant neoplasm of the cerebrum, I102313Malignant neoplasm of the tongue at the transition zone, I102314Malignant neoplasm of the abdominopelvic connective tissue, I102315Abdominopelvic malignant neoplasm, I102639Malignant neoplasm of the upper mammary gland, I102970Malignant neoplasm of the upper inner quadrant of the mammary gland, I102971Malignant neoplasm of the lower inner quadrant of the mammary gland, I102972Malignant neoplasm of the upper outer quadrant of the mammary gland, I102973Malignant neoplasm of the lower outer quadrant of the mammary gland, I102998Malignant neoplasm of the central glandular body of the mammary gland, I102999Malignant neoplasm of the axillary recess of the mammary gland, I103083Malignant neoplasm of the upper extremity, I103085Malignant neoplasm of the lower extremity, I103101Malignant neoplasm of the bile ducts, I103225Malignant neoplasm of the occipital lobe of the brain n.c, I103226Malignant neoplasm of the craniopharyngeal duct, I103335Malignant neoplasm of the anterior surface of the epiglottis, I103342Malignant neoplasm of the epiphysis, I103467Malignant neoplasm of the junction between the hard and soft palate, I103469Malignant neoplasm of the pluriglandular endocrine glands n.c, I103470Malignant neoplasm of an extremity, I103484Malignant neoplasm of autonomic nerves n.c, I103491Malignant neoplasm of the cranial nerves n.c, I103504Malignant neoplasm of the nerves of the upper extremity n.c, I103903Malignant neoplasm of the female reproductive organs n.c, I103964Malignant neoplasm of the abdominal nerves n.c, I103965Malignant neoplasm of the pelvic nerves n.c, I103966Malignant neoplasm of the trunk nerves n.c, I104006Malignant neoplasm of the nerves of the lower limbs n.c, I104062Non-melanoma malignant neoplasm of the skin of the lower limbs n.c, I104144Malignant neoplasm of the thoracic nerves n.c, I104385Malignant neoplasm of the abdominopelvic nerves n.c, I104386Malignant neoplasm of the urinary bladder sphincter, I104480Malignant neoplasm of the oral vestibule, I104488Malignant neoplasm of the rectosigmoid junction, I104770Malignant neoplasm of the digestive system n.e.c, I104900Malignant neoplasm of the postcricoid region, I104907Pulmonary malignant neoplasm, I105337Malignant neoplasm of the lateral wall of the oropharynx, I105338Malignant neoplasm of the posterior wall of the oropharynx, I105339Malignant neoplasm of the oropharynx, I105343Malignant neoplasm of the pancreatic body, I105344Malignant neoplasm of the pancreatic tail, I105736Malignant neoplasm on the outside of the lip, I105738Malignant neoplasm of the inside of the lip, I105739Malignant neoplasm of the lip commissure, I106101Malignant neoplasm of the gill slit, I106105Malignant neoplasm of the posterior wall of the nasopharynx, I106106Malignant neoplasm of the lateral wall of the nasopharynx, I106112Malignant neoplasm of the nasopharynx, I106144Malignant neoplasm of the Müller duct in women, I106523Malignant neoplasm of the long bones of the upper limbs n.c, I106526Malignant neoplasm of the long bones of the lower limbs n.c, I106527Malignant neoplasm of the short bones of the lower limbs, I106528Malignant neoplasm of the limb bones n.c, I106538Malignant neoplasm of articular cartilage n.c, I106829Malignant neoplasm of the laryngeal cartilage n.c, I106840Malignant neoplasm of the short bones of the upper limbs n.c, I107038Malignant neoplasm of the anterior stomach wall n.c, I107040Malignant neoplasm of the duodenojejunal junction, I107094Malignant neoplasm of the posterior wall of the hypopharynx, I107279Malignant neoplasm of a non-descended testicle, I107749Malignant neoplasm of the trachea, I110607Malignant neoplasm of the male genital organs, I110834Malignant neoplasm of the frontal lobe, I111155Carcinoma of the upper lobe bronchus, I111628Malignant neoplasm of the nipple and areola, I111629Malignant neoplasm of the lacrimal gland and lacrimal ducts, I111633Malignant melanoma of the ear and external auditory canal, I112084Malignant neoplasm of the temporal lobe of the brain, I112085Malignant neoplasm of the parietal lobe, I11306Malignant neoplasm of the corpus uteri, I115345Carcinoma of the colon and sigmoid colon, I12785Malignant neoplasm of the retroperitoneum, I12791Malignant neoplasm of the pleura, I128954Undifferentiated sarcoma of the liver, I13430Malignant neoplasm of the anal canal, I13895Malignant neoplasm of the urinary bladder, I14845Malignant neoplasm of the neck of the bladder, I15288Malignant neoplasm of the posterior bladder wall, I15360Malignant neoplasm of the lateral bladder wall, I15411Malignant neoplasm of the anterior bladder wall, I15482Malignant neoplasm of the urinary organs, I15786Hepatoblastoma, I15845Malignant neoplasm of the liver, I16027Malignant neoplasm of the brain, I16258Malignant neoplasm of the testicle, I16949Carcinoma of the maxillary sinus, I17123Malignant neoplasm of the tongue, I17254Kaposi´s syndrome, I17359Malignant neoplasm of the cloacal region, I17389Malignant neoplasm of the anus, I18052Breast cancer, I18119Malignant neoplasm of the rectum, I18447Malignant neoplasm of the spleen, I18790Malignant melanoma of the canthus, I18831Malignant neoplasm of the lip, I18843Malignant neoplasm of the epididymis, I18984Malignant neoplasm of the adrenal gland, I19100Malignant neoplasm of the adrenal cortex, I19178Mesothelioma, I19323Malignant neoplasm, I19879Malignant neoplasm of the kidney, I20177Malignant neoplasm of the renal pelvis, I20215Pleural mesothelioma, I20619Malignant neoplasm of the thyroid gland, I20685Malignant neoplasm of the ostium ureteris, I20717Malignant neoplasm of the ovary, I20815Malignant neoplasm of the pancreas, I21067Malignant neoplasm of the penis, I22071Malignant neoplasm of the spermatic cord, I22232Malignant neoplasm of the scrotum, I22423Malignant neoplasm of the trigonum vesicae, I22501Malignant neoplasm of the urachus, I22610Malignant neoplasm of the ureter, I22762Malignant neoplasm of the urethra, I22933Malignant neoplasm of the uterus, I22961Malignant neoplasm of the vagina, I23075Malignant neoplasm of the vulva, I23296Malignant neoplasm of the intestine, I23597Malignant neoplasm of the paraurethral gland, I23846Malignant neoplasm of the ectocervix, I23916Malignant neoplasm of the endocervix, I24593Malignant neoplasm of the main bronchus, I24721Malignant neoplasm of the jejunum, I24845Malignant neoplasm of the skin, I24894Malignant neoplasm of the base of the tongue, I24912Malignant neoplasm of the cardia, I25251Carcinoma of the outer upper lip, I25258Carcinoma of the outer lower lip, I25262Malignant neoplasm of the inner side of the upper lip, I25265Malignant neoplasm of the inside of the lower lip, I25279Malignant neoplasm of the back of the tongue, I25287Malignant neoplasm of the lower surface of the tongue, I25294Malignant neoplasm of the tonsil of the tongue, I25301Malignant neoplasm of the parotid gland, I25307Malignant neoplasm of the submandibular gland, I25313Malignant neoplasm of the sublingual gland, I25320Malignant neoplasm of the gums, I25323Malignant neoplasm of the floor of the mouth, I25324Malignant neoplasm of the buccal mucosa, I25330Malignant neoplasm of the hard palate, I25333Malignant neoplasm of the soft palate, I25336Malignant neoplasm of the uvula, I25381Malignant neoplasm of the tonsils, I25382Malignant neoplasm of the palatal arch, I25385Malignant neoplasm of the piriform recess, I25391Malignant neoplasm of the hypopharynx, I25392Malignant neoplasm of the Waldeyer pharyngeal ring, I25395Malignant neoplasm of the esophagus, I25397Malignant neoplasm of the cervical esophagus, I25398Malignant neoplasm of the thoracic esophagus, I25399Malignant neoplasm of the abdominal esophagus, I25400Malignant neoplasm of the pylorus, I25404Malignant neoplasm of the duodenum, I25410Malignant neoplasm of the ileum, I25413Malignant neoplasm of the small intestine, I25421Malignant neoplasm of the pancreatic duct, I25427Malignant neoplasm of the islets of Langerhans, I25430Malignant neoplasm of the paranasal sinus, I25438Malignant neoplasm of the nasal cavity, I25446Malignant neoplasm of the middle ear, I25457Malignant neoplasm of the ethmoid sinus, I25463Malignant neoplasm of the frontal sinus, I25467Malignant neoplasm of the sphenoid sinus, I25472Malignant neoplasm of the glottis, I25474Malignant neoplasm of the subglottis, I25481Malignant neoplasm of the thymus, I25484Malignant neoplasm of the heart, I25496Malignant neoplasm of the spine, I25499Malignant neoplasm of the rib, I25671Malignant neoplasm of the flexura coli sinistra, I26089Malignant neoplasm of the gallbladder, I27787Malignant neoplasm of the endometrium, I29848Malignant neoplasm of the edge of the tongue, I29869Malignant neoplasm of the anterior part of the floor of the mouth, I29872Malignant neoplasm of the lateral part of the floor of the mouth, I29875Malignant neoplasm of the palate, I29882Malignant neoplasm of the retromolar region, I29888Malignant neoplasm of the tonsillar fossa, I29892Malignant neoplasm of the epiglottic vallecula, I29931Malignant neoplasm of the oropharynx, I29934Malignant neoplasm of the upper third of the esophagus, I29935Malignant neoplasm of the middle third of the esophagus, I29936Malignant neoplasm of the lower third of the esophagus, I29937Malignant neoplasm of the ventricular fundus, I29941Malignant neoplasm of the corpus ventriculi, I29944Malignant neoplasm of the antrum pyloricum, I29947Malignant neoplasm of the small curvature of the stomach, I29950Malignant neoplasm of the large gastric curvature, I29952Malignant neoplasm of a Meckel´s diverticulum, I29955Malignant neoplasm of the colon, I29956Malignant neoplasm of the caecum, I29957Malignant neoplasm of the vermiform appendix, I29959Malignant neoplasm of the ascending colon, I29964Malignant neoplasm of the flexura coli dextra, I29966Malignant neoplasm of the transverse colon, I29971Malignant neoplasm of the descending colon, I29972Malignant neoplasm of the sigmoid colon, I29975Malignant anorectal neoplasm, I29978Intrahepatic bile duct carcinoma, I29984Angiosarcoma of the liver, I29985Malignant neoplasm of the extrahepatic bile duct, I29993Malignant neoplasm of the pancreatic head, I29998Malignant neoplasm of the larynx, I30003Malignant neoplasm of the supraglottis, I30013Malignant neoplasm of the middle lobe of the lung, I30019Malignant neoplasm of the lower lobe of the lung, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas, I30026Malignant neoplasm of the mediastinum anterius, I30029Malignant neoplasm of the posterior mediastinum, I30032Malignant neoplasm of the mediastinum, I30036Malignant neoplasm of the lip skin, I30041Malignant neoplasm of the eyelid, I30064Facial skin carcinoma, I30072Malignant neoplasm of the scalp, I30085Malignant neoplasm of the skin of the trunk, I30088Carcinoma of the skin of the upper limbs, I30097Peritoneal mesothelioma, I30099Pericardial mesothelioma, I30100Kaposi´s sarcoma of the skin, I30101Kaposi´s sarcoma of the soft tissue, I30102Kaposi´s sarcoma of the palate, I30103Kaposi´s sarcoma of the lymph nodes, I30104Kaposi´s sarcoma of the conjunctiva, I30109Malignant neoplasm of the pelvic peritoneum, I30114Malignant neoplasm of the peritoneum, I30118Malignant neoplasm of the connective tissue of the head, I30149Malignant neoplasm of the connective tissue of the thorax, I30159Malignant neoplasm of the soft tissues of the abdomen, I30166Malignant neoplasm of the soft tissues of the pelvis, I30177Malignant neoplasm of the soft tissues of the back, I30179Malignant neoplasm of the connective tissue, I30209Malignant neoplasm of the labia majora pudendi, I30213Malignant neoplasm of the labia minora pudendi, I30217Malignant neoplasm of the clitoris, I30220Malignant neoplasm of the isthmus uteri, I30223Malignant neoplasm of the myometrium, I30225Malignant neoplasm of the uterine fundus, I30228Malignant neoplasm of the uterine tube, I30231Malignant neoplasm of the ligamentum latum uteri, I30234Malignant neoplasm of the ligamentum teres uteri, I30237Malignant neoplasm of the parametrium, I30243Malignant neoplasm of the uterine adnexa, I30251Malignant neoplasm of the placenta, I30256Malignant neoplasm of the penis shaft, I30262Malignant neoplasm of the apex vesicae, I30263Malignant neoplasm of the conjunctiva, I30273Malignant neoplasm of the cornea, I30278Malignant neoplasm of the retina, I30284Malignant neoplasm of the choroid, I30323Malignant neoplasm of the orbit, I30328Malignant neoplasm of the eye, I30330Malignant neoplasm of the meninges, I30333Malignant neoplasm of the meninges, I30336Malignant neoplasm of the spinal cord membranes, I30357Malignant neoplasm of a cerebral ventricle, I30366Malignant neoplasm of the brain stem, I30370Malignant neoplasm of the spinal cord, I30373Malignant neoplasm of the cauda equina, I30374Malignant neoplasm of the olfactory nerves, I30375Malignant neoplasm of the optic nerve, I30377Malignant neoplasm of the vestibulocochlear nerve, I30379Malignant neoplasm of a cranial nerve, I30390Malignant neoplasm of the adrenal medulla, I30391Malignant neoplasm of the parathyroid gland, I30400Malignant neoplasm of the pituitary gland, I30414Malignant neoplasm of the glomus caroticum, I30423Malignant neoplasm of endocrine glands, I30428Malignant neoplasm of the head, I30432Malignant neoplasm of the thorax, I30439Malignant neoplasm of the abdomen, I30447Malignant neoplasm of the pelvis, I30824Malignant neoplasm of the stomach, I3395Malignant neoplasm of the skull bone, I3397Malignant neoplasm of the facial bone, I3402Malignant neoplasm of the mandibular bone, I3406Malignant neoplasm of the pelvic bone, I3412Malignant melanoma of the lip, I3416Malignant melanoma of the face, I3422Malignant melanoma of the neck, I3435Malignant melanoma of the lower limbs, I74671Hepatocellular carcinoma, I81241Liver teratoma, I84686Malignant neoplasm of the oral cavity, I84688Malignant neoplasm of the nasopharyngeal floor, I84691Malignant neoplasm of the pharynx, I84705Malignant neoplasm of the clavicle, I84706Malignant neoplasm of the sternum, I84708Malignant melanoma, I84771Malignant neoplasm of the lower jaw gums, I84773Malignant neoplasm of the maxillary gums, I84905Malignant neoplasm of the aryepiglottic fold, I84940Malignant neoplasm of the ampulla hepatopancreatica, I84958Malignant neoplasm of large salivary glands, I84962Malignant neoplasm of the transitional region of the oropharynx, I84966Malignant neoplasm of the roof of the nasopharynx, I85031Malignant neoplasm of the prepuce, I85034Malignant neoplasm of the corpus callosum, I85035Malignant neoplasm of the central nervous system, I85466Malignant uteroovarian neoplasm, I85493Malignant neoplasm of unknown primary localization, I85652Malignant neoplasm of the intra- and extrahepatic bile ducts, I85653Malignant neoplasm of the pancreatic neck, I85684Malignant neoplasm of a descended testicle, I85687Malignant neoplasm of the seminal vesicle, I86600Malignant neoplasm of the prostate, I93110Kaposi´s sarcoma of several organs, I9466Malignant neoplasm of the glans penis, I96395Malignant melanoma of the trunk n.c, I96441Malignant melanoma of the upper extremity n.c, I96847Mesothelioma of the mediastinum Show more >>
DDD 0.6 g O
Therapeutic area Oncological diseases Solid tumors
Reason for procedure Initial assessment
Regulatory status Conditional Approval
Specialty Bundling ACT change

Therapeutic indication of the resolution

Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,

– who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and

– who have not received a prior NTRK inhibitor

– who have no satisfactory treatment options
Subpopulation Indication Comparator
Adult and paediatric patients aged 12 years and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, locally advanced or metastatic disease, or disease for which surgical resection is likely to result in severe morbidity, and who have not previously received an NTRK inhibitor and for whom no satisfactory therapeutic options are available. Patient-specific therapy with selection of - Best-Supportive-Care and - Surgical resection likely to result in severe morbidity for which clinical benefit can be expected on a patient-specific basis.

Studies and Results

No. of studies
(best subpopulation) 		0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + historical comparison)
ACT change 07.07.2020 – EMA Änderung der Zulassung

  • Clinical trials
    • The STARTRK-2 trial is a Phase II, uncontrolled clinical study that has been ongoing since November 2015.
    • The STARTRK-NG trial is an uncontrolled clinical study of Phase I/Ib non-controlled dose-escalation study, followed by a dose-extension phase, in paediatric and adult patients up to the age of 22 with relapsed or refractory solid extracranial tumours or primary tumours of the central nervous system with or without NTRK, C-ros oncogene 1 or anaplastic lymphoma kinase fusions.

Adult and paediatric patients aged 12 years and over with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have locally advanced or metastatic disease or a condition where surgical resection has a high probability of resulting in severe morbidity, and who have not previously received an NTRK inhibitor and for whom no satisfactory treatment options are available

  • The additional benefit of entrectinib over the appropriate comparator therapy is not proven.
  • Consequently, the evidence provided does not allow for a comparison with the appropriate comparator therapy; therefore, no additional benefit of entrectinib as monotherapy has been demonstrated for the treatment of adult and paediatric patients aged 12 years and over with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have locally advanced or metastatic disease or a condition where surgical resection has a high probability of resulting in severe morbidity, and for whom no satisfactory treatment options are available, is not proven.
  • Overall assessment
    • For the benefit assessment, the pharmaceutical manufacturer has submitted the results from the STARTRK-2 registration trial in adult patients with NTRK gene fusions, as well as data on paediatric patients from the STARTRK-NG trial regarding treatment with entrectinib.
    • The therapeutic indication for entrectinib covers various tumour entities and, consequently, tumour diseases with different courses and prognoses. The G-BA therefore considers it appropriate and necessary to assess the results separately for each tumour entity.
    • Data from the STARTRK-2 study are available for the latest data cut-off, covering a total of 21 tumour entities treated with entrectinib. The number of patients per tumour entity varies considerably, ranging from 1 to a maximum of 16 patients. Data from ≥ 10 patients are available for only three tumour entities: soft tissue sarcoma (N=11 NTRK EE; N=13 NTRK SE), non-small cell lung cancer (N=12 NTRK EE; N=14 NTRK SE) and secretory salivary gland carcinoma (N=12 NTRK EE; N=16 NTRK SE).
    • The registration trial is an uncontrolled clinical study and therefore does not include a control group. Overall, the evidence submitted by the pharmaceutical manufacturer to demonstrate additional benefit lacks a comparison with the appropriate comparator therapy.
    • The data on paediatric patients submitted by the pharmaceutical manufacturer are not suitable for assessing additional benefit in the present therapeutic indication.
  • Conclusion
    • Consequently, the proof submitted does not allow for a comparison with the appropriate comparator therapy, which is why an additional benefit of entrectinib is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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