Bristol's Zenbexus Wins FDA Nod, Debuts Novel Myeloma Class
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- FDA approved Bristol Myers Squibb's oral drug iberdomide (brand name Zenbexus) on Thursday for advanced multiple myeloma patients who've had at least one prior line of therapy
- Iberdomide will be used in combination with Darzalex and dexamethasone, per Bristol's announcement
- The approval marks the debut of a new drug class for multiple myeloma, according to Bristol's chief medical officer, who said it opens "venues for many more potential combinations"
- Zenbexus is the first drug cleared by U.S. regulators using a more sensitive measure of remission
Why it matters: Bristol becomes the first company to bring a novel drug class to multiple myeloma, with its CMO explicitly flagging the potential for many more combination regimens. The approval also validates a more sensitive remission measure as an FDA-cleared endpoint — the first time the agency has greenlit a drug on that basis.
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