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Oct 2Fri
  1. aacrjournals.org80

    In Regulatory First, Myeloma Drug Approved Based on MRD Negativity

    The FDA has approved iberdomide for multiple myeloma on the basis of minimal residual disease negativity, the first approval for the disease to use that endpoint. Iberdomide also represents a new generation of targeted protein degraders, with several more potent cereblon E3 ligase modulators already in clinical development.

    Why it matters: First myeloma approval based on MRD negativity and a new class of cereblon E3 ligase modulators advancing.

Oct 1Thu
  1. fda.gov61

    FDA approves first drug to improve functional capacity and symptoms in children with rare inherited heart condition

    The FDA approved Camzyos (mavacamten) as the first treatment to improve functional capacity and symptoms in children with symptomatic obstructive hypertrophic cardiomyopathy, extending approval to pediatric patients weighing at least 30 kg, after adult approval in 2022. Efficacy was supported by the phase 3 SCOUT-HCM trial in 44 patients aged 12-18, where once-daily dosing for 28 weeks significantly reduced the Valsalva LVOT gradient versus placebo. The drug carries a boxed warning for heart failure risk and is available only through the Camzyos REMS program.

    Why it matters: First pediatric approval for symptomatic oHCM, backed by phase 3 data in adolescents.

Sep 4Fri
  1. nature.com65

    Newest glue degrader nabs multiple myeloma approval

    Bristol Myers Squibb won accelerated approval for iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase (Darzalex Faspro) and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy. Iberdomide is the newest of BMS's molecular glue degraders to reach the market.

    Why it matters: Accelerated approval of a new glue degrader expands the multiple myeloma treatment landscape.

Aug 21Fri
  1. fiercepharma.com47

    Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns

    The FDA has issued Xspray Pharma a third Complete Response Letter for Dasynoc, its optimized version of Bristol Myers Squibb's Sprycel (dasatinib) for chronic myeloid leukemia and acute lymphoblastic leukemia. The letter cites manufacturing observations at third-party producer NerPharMa in Italy and requests additional commercial-scale batch data; the FDA has yet to decide whether a reinspection is needed. Xspray plans to resubmit the application before the end of the year and continues U.S. launch preparations.

Aug 14Fri
  1. STAT News81

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

    The FDA approved Bristol Myers Squibb's oral drug iberdomide, branded Zenbexus, for advanced multiple myeloma in patients who have received at least one prior line of therapy. It is the first drug in a new class of medicines for the blood cancer and the first cleared using a more sensitive measure of remission. Zenbexus will be used in combination with Darzalex and dexamethasone, and Bristol sees the class opening possibilities for more combinations.

    Why it matters: First approval of a novel drug class for multiple myeloma, with a new remission standard used by FDA.

  2. FiercePharma82

    BMS bags first FDA approval for CELMoD franchise with Zenbexus multiple myeloma nod

    The FDA has granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide), the first cleared CELMoD therapy, in combination with Johnson & Johnson's Darzalex and dexamethasone for adults with previously treated multiple myeloma. The approval rests on the phase 3 Excaliber-RRMM trial, where the regimen achieved an MRD-negative complete response rate of 41% versus 21% for Darzalex, Velcade and dexamethasone at a median follow-up of 16 months. BMS must provide confirmatory PFS data expected this year, and its second CELMoD, mezigdomide, faces an FDA decision date of May 13, 2027.

    Why it matters: First approval for a CELMoD drug and first new myeloma drug cleared directly on MRD as an endpoint.

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