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布里斯托尔加速批准伊伯多胺治疗多发性骨髓瘤
2026-08-14 05:29
- The US FDA granted accelerated approval to Bristol Myers Squibb's (BMY) Zenbexus (iberdomide), in combination with Johnson & Johnson's (JNJ) Darzalex (daratumumab), hyaluronidase-fihj and dexamethasone, as a second-line treatment for multiple myeloma.
- Approval was based on the results of the EXCALIBER-RRMM trial, which had a primary endpoint of minimal residual disease (MRD)-negative complete response at any time. Those on the iberdomide combo regimen had an MRD-negative CR rate of 41% compared to 21% in the daratumumab, hyaluronidase-fihj and dexamethasone group.
- Labeling for Zenbexus includes a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism. As a result, the drug is only available through a REMS program.
More on Bristol Myers Squibb
- AstraZeneca, Bristol Myers Squibb To Merge? Let's Consider The Pros And Cons
- Bristol-Myers Squibb Company (BMY) Q2 2026 Earnings Call Transcript
- Bristol-Myers Squibb Company 2026 Q2 - Results - Earnings Call Presentation
- Cytokinetics sues Bristol-Myers to avoid patent dispute
- AstraZeneca held talks with Bristol-Myers through spring, summer - FT
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