Bristol-Myers granted three applications for myeloma candidate Abecma

Bristol Myers (BMY) and 2seventy bio (TSVT) announced that the FDA has accepted the companies’ supplemental Biologics License Application for Abecma with the KarMMa-3 study that investigated the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The FDA has assigned a Prescription Drug User Fee Act goal date of December 16. The European Medicines Agency has also validated Bristol Myers Squibb’s Type II variation application for Abecma based on the KarMMa-3 study. Validation of the application confirms the submission is complete and begins the procedure and scientific assessment. In addition, Japan’s Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s supplemental New Drug Application for Abecma based on the KarMMa-3 study. The three regulatory applications were based on interim results from the KarMMa-3 study evaluating Abecma compared with standard combination regimens. Results showed treatment with Abecma demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and overall response rate, and safety results were consistent with the well-established and generally predictable safety profile of Abecma.