Bristol Myers’ application for subcutaneous nivolumab accepted by FDA

Bristol Myers announced that the FDA has accepted the Biologics License Application – BLA – for the subcutaneous formulation of Opdivo, or nivolumab, co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, or subcutaneous nivolumab, across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025. Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 and Cminss, the study’s co-primary endpoints, vs. intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.