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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 14Wed
  1. fda.gov91

    FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

    The FDA expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln), given with BCG, to adults with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer, the first FDA-approved treatment for that disease. The decision relied on evidence from Anktiva's earlier approval for carcinoma in situ, where a trial showed a majority of adults achieved a complete response and many maintained it for at least 12 months. The FDA is finalizing draft guidance to let developers use CIS study evidence for papillary-only NMIBC approvals.

    Why it matters: FDA extends Anktiva to BCG-unresponsive papillary-only NMIBC and sets a precedent for cross-indication evidence use.

  2. fda.gov76

    FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

    On October 14, 2026, the FDA expanded approval of nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, an ImmunityBio subsidiary) with BCG to cover adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors, beyond the prior indication limited to carcinoma in situ. The agency extrapolated efficacy from Cohort A of QUILT-3.032, a single-arm trial of 77 patients, which showed a complete response rate of 62%. The recommended dose is 400 mcg intravesically with BCG weekly for 6 weeks induction, followed by maintenance for up to 37 months.

Oct 9Fri
  1. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 8Thu
  1. fda.gov80

    FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancer

    The FDA approved tucatinib (Tukysa, Seagen, a Pfizer subsidiary) with trastuzumab and pertuzumab on October 7, 2026, for maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In the 654-patient HER2CLIMB-05 trial, median progression-free survival was 24.9 months with tucatinib 300 mg twice daily versus 16.3 months with placebo (HR 0.64, p<0.0001). The label carries a boxed warning for hepatotoxicity; overall survival data were immature.

    Why it matters: FDA approval extends tucatinib to first-line maintenance, with PFS results from a randomized phase 3 trial.

Oct 7Wed
  1. fda.gov40

    Rare Disease Drug Approvals

    FDA's CDER lists recent rare disease drug approvals on its Accelerating Rare Disease Cures Program page. In 2026 alone these include Camzyos for an inherited heart condition in children, Emcitate for MCT8 deficiency, Isembyld for muscle loss in spinal muscular atrophy, and Zanvastro for Alexander Disease, among others. The list spans 2021 to 2026 and links to the underlying FDA news releases.

Oct 3Sat
  1. fda.gov50

    Oncology (Cancer)/Hematologic Malignancies Approval Notifications

    The FDA issued a run of oncology and hematology approvals from July 31 to October 2, 2026. They include pirtobrutinib (Jaypirca, Eli Lilly) for previously untreated CLL or SLL without 17p deletion on October 2, belzutifan plus lenvatinib for advanced clear-cell renal cell carcinoma on September 24, lirafugratinib (Lyrfigtu, Elevar) for FGFR2-rearranged cholangiocarcinoma on September 23, imlunestrant plus abemaciclib for ESR1-mutated breast cancer on September 18, and daraxonrasib (RASONQUE, Revolution Medicines) for metastatic pancreatic adenocarcinoma on August 26. Accelerated approvals in the batch cover sevabertinib for HER2-mutated NSCLC, camizestrant for ESR1-mutated breast cancer, iberdomide for multiple myeloma, and vusolimogene oderparepvec plus nivolumab for melanoma.

Sep 18Fri
  1. ema.europa.eu40

    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026

    The EMA's CHMP recommended 12 new medicines for approval at its September 2026 meeting, including Frehemgo (denecimig) for bleeding prophylaxis in haemophilia A, Gevalka (ensartinib) for ALK-positive advanced non-small cell lung cancer, and Povofortay (povorcitinib), the first oral daily treatment for adults with hidradenitis suppurativa refractory or intolerant to anti-TNF therapy. Two initial marketing authorisation applications were withdrawn, Isembyld for 5q spinal muscular atrophy and Zinmyleo for chemotherapy-induced myelosuppression. Re-examinations of negative opinions for Kemsu, Meplyffa and Qezzaqar will follow once grounds are received.

Sep 5Sat
  1. fda.gov59

    FDA Grants Accelerated Approval to a New Breast Cancer Treatment

    The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant), an oral tablet, combined with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors show an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, detected by the FDA-authorized Guardant360 CDx companion diagnostic. In the pivotal trial, estimated median progression-free survival was 16 months versus 9.2 months for continuing an aromatase inhibitor plus a CDK4/6 inhibitor. The label carries a boxed warning for irregular heart rhythm, and confirmatory trials are required to verify clinical benefit.

    Why it matters: First FDA approval of a cancer therapy guided by ctDNA resistance-mutation detection before imaging shows progression.

Aug 26Wed
  1. fda.gov74

    FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

    The FDA approved Revolution Medicines' Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a 500-patient randomized trial, Rasonque improved median overall survival to 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the user fee deadline, under Breakthrough Therapy, Orphan Drug and Priority Review designations and the National Priority Voucher pilot program.

    Why it matters: First-in-class RAS inhibitor approval gives a survival benefit in metastatic pancreatic adenocarcinoma, a high-mortality cancer with few options.

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