FDA Approves First CELMoD Drug for Multiple Myeloma
The oral regimen won approval after a planned analysis showed significantly higher minimal residual disease rates than standard therapy, the company said.
- On Thursday, the Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's Zenbexus, an oral combination treatment for patients with relapsed or refractory multiple myeloma.
- Zenbexus belongs to a new class of drugs called CELMoDs that harness the body's waste disposal system to eliminate diseased cells more effectively than older treatments.
- Clinical data showed 41% of recipients achieved "MRD-negative" status compared with 21% for Velcade, while the $28,000 monthly price led William Blair analyst Matt Phipps to forecast sales past $1 billion by 2031.
- The FDA mandated a restricted distribution program and issued a boxed warning regarding embryo-fetal toxicity, while Bristol Myers is simultaneously testing Zenbexus in a maintenance study for transplant patients.
- Facing revenue declines where sales for Revlimid plunged $2.8 billion last year, Bristol Myers is using this approval to sustain its multiple myeloma franchise while developing a second CELMoD treatment.
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FDA Approves First CELMoD Drug for Multiple Myeloma
(MedPage Today) -- The FDA granted accelerated approval to the first cereblon E3 ligase modulation (CELMoD) therapy for relapsed or refractory multiple myeloma, the agency announced on Thursday. An oral drug, iberdomide (Zenbexus) is approved...
US FDA approves Bristol Myers’ blood cancer treatment - Regional Media News
Aug 13 (Reuters) - The U.S. FDA on Thursday approved Bristol Myers Squibb's oral combination treatment for patients with a rare form of blood cancer whose illness had relapsed or not responded to other treatments, the health regulator said. The drug, iberdomide, with brand name Zenbexus, is given in combination with J&J's Darzalex and dexamethasone, a prescription medication used to reduce inflammation. Iberdomide was being tested in patients wi…
US FDA approves Bristol Myers’ blood cancer treatment
Aug 13 (Reuters) - The U.S. FDA on Thursday approved Bristol Myers Squibb's combination treatment for patients with a rare form of blood cancer whose illness had relapsed or not responded to other treatments, the health regulator said. The drug, ...
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