Ipilimumab (3) – Yervoy®

Melanoma, ≥ 12 to < 18 years

Characteristics

Start date 15.02.2018 – Marketing authorisation: 18.01.2018
Resolution 02.08.2018
INN Ipilimumab
Brand name Yervoy®
Pharm. company Bristol-Myers Squibb GmbH & Co. KGaA
G-BA Procedure ID D-350
ATC code L01FX04 Other monoclonal antibodies and antibody drug conjugates (L01FX)
ICD-10 codes (AIS) 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
Alpha-ID codes (AIS) I111156Malignant melanoma of the hairy scalp, I111633Malignant melanoma of the ear and external auditory canal, I18282Malignant melanoma, I18791Malignant melanoma of the eyelid, I3412Malignant melanoma of the lip, I3416Malignant melanoma of the face, I96395Malignant melanoma of the trunk n.c, I96441Malignant melanoma of the upper extremity n.c, I96442Malignant melanoma of the lower extremity n.c
DDD 10 mg P
Therapeutic area Oncological diseases Melanoma (MA)
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

YERVOY as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older.
Subpopulation Indication Comparator
Treatment of advanced (non-resectable or metastatic) melanoma in adolescents aged 12 years and older. Therapy according to the doctor's instructions

Studies and Results

No. of studies
(best subpopulation) 		1 (CA184-178)
Study design
(best subpopulation) 		Evidence transfer
Meta analysis
(best subpopulation) 		no

  • Clinical trials
    • The CA184-178 trial was a single-arm, open-label trial of ipilimumab in adolescents (aged ≥ 12 to < 18 years) with previously treated or untreated advanced (unresectable or metastatic) stage III or IV melanoma.

Young people aged 12 years and over

  • The additional benefit is not proven
  • For ipilimumab as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents aged 12 years and over, additional benefit is not proven compared with the appropriate comparator therapy, ‘treatment at the doctor’s discretion’.
  • Given the current state of scientific knowledge and for methodological reasons, it is not appropriate to extrapolate the evidence submitted by the pharmaceutical manufacturer from adults to adolescents.
  • Overall assessment / Conclusion
    • For ipilimumab as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents aged 12 years and over, an additional benefit is not proven compared with the appropriate comparator therapy, ‘treatment as the doctor deems appropriate’.
    • Given the current state of scientific knowledge and for methodological reasons, it is not appropriate to extrapolate the evidence from adults to adolescents as presented by the pharmaceutical manufacturer.

Courtesy translation only, please refer to the German original.

Associated procedures



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