FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma.
The drug, iberdomide, will be marketed as Zenbexus and is intended to be used together with Darzalex and dexamethasone in patients who have already received at least one prior treatment.
This approval represents the first introduction of a novel drug class for this blood cancer and is also the first time U.S. regulators have relied on a more sensitive remission measurement to grant clearance.
The decision could expand treatment options for relapsed or refractory multiple myeloma and may influence future development strategies.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA approves Bristol multiple myeloma treatment, marking debut of novel drug class”
read at STAT ↗
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