Skip to content

#免疫治疗

Today 0 items
Oct 14Wed
  1. 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.gov41

    Recently Issued Guidance Documents

    The FDA has released a set of guidance documents for industry and agency staff issued from July to September 2026. The list includes final guidances on blood collection and storage systems for blood components using the buffy coat method, formal PDUFA meetings, cancer clinical trial eligibility criteria on laboratory values, washout periods and performance status, and FAQs for cellular and gene therapy products. Draft guidances cover premarket approval electronic submission templates, potency assessment of active immunotherapy products, container closure systems for drugs, biologicals and biosimilars.

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.

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