Avelumab (3) – Bavencio®

Metastatic Merkel-cell carcinoma (MCC)

Characteristics

Start date 01.04.2020 – Marketing authorisation: 18.09.2017
Resolution 01.10.2020
INN Avelumab
Brand name Bavencio®
Pharm. company Merck Serono GmbH
G-BA Procedure ID D-534
ATC code L01FF04 PD-1/PDL-1 inhibitors (L01FF)
ICD-10 codes (AIS) 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
Alpha-ID codes (AIS) I24848Merkel cell carcinoma, I30036Malignant neoplasm of the lip skin, I30041Malignant neoplasm of the eyelid, I30053Malignant neoplasm of the skin of the ear, I30064Facial skin carcinoma, I30072Malignant neoplasm of the scalp, I30085Malignant neoplasm of the skin of the trunk, I30088Carcinoma of the skin of the upper limbs, I30093Carcinoma of the skin of the hip
DDD 50 mg P
Therapeutic area Oncological diseases Melanoma (MA), Merkel-cell carcinoma (MCC)
Reason for procedure Reassessment: Loss of orphan status
Original resolution: Avelumab (1) (16.03.2018)

Therapeutic indication of the resolution

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Subpopulation Indication Comparator
Adult patients with metastatic Merkel cell carcinoma (MCC); first-line therapy Therapy according to the doctor's instructions

Studies and Results

No. of studies
(best subpopulation) 		0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + no comparison)

Adult patients with metastatic Merkel cell carcinoma (MCC); first-line treatment

  • An additional benefit is not proven for the first-line treatment of adult patients with metastatic Merkel cell carcinoma.
  • Consequently, additional benefit is not proven.
  • The single-arm study JAVELIN Merkel 200 submitted is, in principle, only suitable for comparing individual arms from different studies.
  • For comparison with the appropriate comparator therapy, the pharmaceutical manufacturer identifies the single-arm KEYNOTE-017 study. Due to a lack of information on the study population, this study is not suitable for comparison and is excluded by the pharmaceutical manufacturer.
  • Consequently, the pharmaceutical manufacturer was unable to provide suitable comparative data for the assessment of additional benefit. An assessment of additional benefit is not possible on the basis of this data.

Courtesy translation only, please refer to the German original.

Associated procedures



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