The Priority Review

Tag

Oncology

4 stories

Stories

  1. Approvals

    FDA expands Anktiva indication to high-grade papillary bladder cancer

    On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors. The agency extrapolated from earlier data in patients with carcinoma in situ.

  2. Clinical trials

    Roche posts IMpower030 results: atezolizumab before surgery in resectable lung cancer

    Hoffmann-La Roche posted results for the Phase 3 IMpower030 trial on October 9, 2026. In the Stage IIB-IIIB wild-type group, median event-free survival was 34.92 months on placebo and 62.78 months on atezolizumab, both plus chemotherapy.

  3. Approvals

    FDA approves tucatinib with trastuzumab and pertuzumab for HER2-positive breast cancer

    On October 7, 2026, the FDA approved Tukysa with trastuzumab and pertuzumab as maintenance treatment for HER2-positive breast cancer. The FDA said median progression-free survival was 24.9 months with tucatinib and 16.3 months with placebo.

  4. Approvals

    FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer

    On October 8, 2026, the FDA approved atezolizumab with a fluoropyrimidine and oxaliplatin for adjuvant treatment of Stage III dMMR colon cancer. The FDA said the ATOMIC trial showed a hazard ratio of 0.50 for disease-free survival.