Bristol Myers Squibb announces that the European Medicines Agency’s CHMP has recommended approval of Opdivo as an adjuvant therapy for patients 12 years of age and older with completely resected stage IIB or IIC melanoma.
This positive opinion is based on safety and efficacy results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death by 58% compared to placebo.
These results were presented at the 2022 annual meeting of the Society for Melanoma Research (SMR). The European Commission, which has the power to approve medicines in the European Union, will now review the CHMP recommendation.
This article is originally published on boursorama.com