05:56 PM EDT, 08/13/2026 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said late Thursday that the US Food and Drug Administration granted accelerated approval to Zenbexus in combination with daratumumab and hyaluronidase-fihj and dexamethasone to treat multiple myeloma.

The approval covers adults who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

The approval is based on phase 3 trial data showing a statistically significant improvement in one of the dual primary endpoints, with minimal residual disease-negative complete response achieved in 41% of patients treated with the Zenbexus combination versus 21% for the comparator regimen.

Full approval for the indication will depend on verification and description of clinical benefit in the confirmatory trial, according to a statement.