Drug & Regulatory STAT News

STAT+: FDA approves Bristol multiple myeloma treatment, marking debut of novel drug class

iberdomideZenbexusmultiple myelomaFDA approval

The Food and Drug Administration on Thursday approved iberdomide, sold as Zenbexus, an oral treatment for advanced multiple myeloma developed by Bristol Myers Squibb. This approval marks the debut of a new class of medicine for the blood cancer and is the first drug cleared by U.S. regulators using a more sensitive measure of remission.

Zenbexus is indicated in combination with Darzalex and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy. Bristol's chief medical officer, Cristian Massacesi, said the approval makes Bristol the first company to bring a novel drug class to multiple myeloma patients, opening avenues for many more potential combinations.

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