The FDA approved Bristol Myers Squibb’s iberdomide (Zenbexus), an oral multiple myeloma treatment intended for patients who have received at least one prior line of therapy. BMS is launching the drug as part of combination therapy with Darzalex and dexamethasone, following an FDA decision that signals broader regulatory interest in newer response measurement approaches. The approval is also being framed as a class debut: Zenbexus represents the start of a new drug class for myeloma in the U.S., and it is the first BMS product cleared using a more sensitive remission measure. BMS said the approval opens the door to additional combination regimens across lines of therapy. For the market, the timing matters because multiple myeloma is one of the most competitive areas of hematology, with ongoing efforts to sequence therapies and improve depth and durability of response. The new oral option is poised to impact how clinicians consider next-line strategies in relapsed/refractory disease.
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