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#小分子/降解剂

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Oct 15Thu
  1. ema.europa.eu90

    EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

    EMA's CHMP has recommended EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma previously treated at least once. In a 500-patient phase 3 study, median overall survival was 12.4 months versus 6.7 with chemotherapy, and median progression-free survival 7.2 versus 3.6 months. The European Commission will now fast-track its decision, with pricing left to Member States.

    Why it matters: CHMP backing via a phased review under 150 days sets precedent for faster EU assessments of priority cancer medicines.

Oct 13Tue
  1. nature.com84

    RevMed’s pancreatic cancer drug first

    The FDA approved Revolution Medicines' Rasonque (daraxonrasib) in August for metastatic pancreatic adenocarcinoma, making it a first-in-class RAS inhibitor for the most common form of pancreatic cancer. Rasonque uses a molecular glue mechanism, binding cyclophilin A and RAS in its GTP-bound 'on' state, unlike KRAS G12C inhibitors such as Lumakras and Krazati. An early-stage trial in September showed promise in lung cancer, raising hopes for use in other hard-to-treat tumors.

    Why it matters: First FDA approval of a pan-RAS inhibitor for metastatic pancreatic adenocarcinoma, with early lung cancer activity.

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.

Sep 10Thu
  1. fiercepharma.com55

    FDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry

    The FDA has approved Bayer's tyrosine kinase inhibitor Hyrnuo for first-line treatment of patients with HER2-mutant non-small cell lung cancer. The approval comes roughly half a year after the FDA cleared Boehringer Ingelheim's rival TKI Hernexeos for a similar setting. The two drugs now compete in the same indication.

    Why it matters: First-line FDA approval in HER2-mutant NSCLC sets up direct competition between Bayer and Boehringer Ingelheim TKIs.

Aug 27Thu
  1. biocentury.com75

    RevMed’s first-in-class pancreatic therapy among fastest CNPV approvals

    FDA approved Revolution Medicines' daraxonrasib (Rasonque) for pancreatic ductal adenocarcinoma, making it the first targeted therapy in the new RAS(ON) inhibitor class and the first new cancer drug cleared under the commissioner's national priority review voucher initiative. Revolution Medicines (NASDAQ:RVMD) is launching the drug immediately at a WAC of $39,800 for a 30-day supply.

    Why it matters: First approval in a new drug class and first under FDA's new priority voucher programme, priced at launch.

Aug 26Wed
  1. FiercePharma68

    FDA greenlights Revolution Medicines' pancreatic cancer gamechanger

    The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib targets Ras in a disease setting with limited options.

    Why it matters: FDA approval of a new Ras inhibitor for metastatic pancreatic cancer matters to clinicians and industry readers.

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. 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.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org