Bristol Myers Squibb announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Opdivo® (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with completely resected stage IIB or IIC melanoma. If the European Commission approves this recommendation, Opdivo® will become the sole PD-1 inhibitor indicated as an adjuvant treatment for patients in stages IIB, IIC, III, as well as stage IV resected melanoma.
On 30 May 2023, the FDA accepted Priority Review for BMS’s NDA for repotrectinib for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer