2023-10-08 09:00:00
Over the summer, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved, among other things, nivolumab for melanoma, futibatinib for cholangiocarcinoma and talquetamab for multiple myeloma.
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In August 2023, the EMA CHMP approved nivolumab as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and over with stage IIB or IIC melanoma that have been completely resected. The basis for approval are the results of the Check-Mate 76K study, a randomized, double-blind study in which adjuvant treatment with nivolumab 480mgQ4W for up to 12 months compared to placebo in 790 patients with completely resected stage IIB melanoma or IIC was examined. In the phase III trial, nivolumab reduced the risk of recurrence or mortality by 58% compared to placebo in people with stage IIB or IIC melanoma with a follow-up of at least 7.8 months. The 12-month relapse-free survival (RFS) was 89% with nivolumab (vs. 79% with placebo). The safety profile of nivolumab was consistent with the results of previous studies.
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K). Updated 27. Juli 2023, Accessed 19.92023. https://clinicaltrials.gov/study/NCT04099251
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#approvals #melanoma #bile #duct #carcinoma #multiple #myeloma
