FDA approves Bristol Myers’ Zenbexus for multiple myeloma

The U.S. Food and Drug Administration has granted approval to Bristol Myers Squibb’s Zenbexus for the treatment of multiple myeloma, the company said on Friday.

Zenbexus, a BCMA-directed bispecific antibody, is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

The approval is based on data from the pivotal Phase 2 MajesTEC-1 trial, which demonstrated an overall response rate of 63% among treated patients. Median duration of response was not reached at the time of data cutoff, with a median follow-up of 14.1 months.

Bristol Myers said it expects to make Zenbexus commercially available in the U.S. in the coming weeks. The company did not disclose pricing details.

Multiple myeloma is a rare blood cancer, and patients who have exhausted standard therapies represent a significant unmet medical need. Zenbexus joins a growing class of BCMA-targeted therapies in the market, including antibody-drug conjugates and chimeric antigen receptor T-cell therapies.

Bristol Myers’ shares were indicated 0.3% higher in early trading on Friday following the announcement.