Five of 10 October FDA approvals were new uses for cancer drugs the FDA had approved before

The Priority Review has published 37 posts tagged FDA since October 2, 2026, and the FDA records behind them hold 10 product approvals dated October 1 to 20. Five of the 10 were cancer drugs, and each of the five added a use to a medicine the FDA had approved before, the agency's own pages show. The other records are mostly regulatory notices: 6 final orders on medical devices, 3 notices withdrawing or correcting generic drug approvals, 2 priority review vouchers, 3 final guidances and several requests for public input. None of the posts reports a complete response letter.

Cancer drugs: five approvals, all new uses

Each of the five cancer approvals went to a drug with an earlier FDA approval:

pirtobrutinib (Jaypirca, Eli Lilly and Company), October 2, for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. The FDA list of ongoing cancer accelerated approvals shows a 1/27/2023 accelerated approval in mantle cell lymphoma.
tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer), October 7, as maintenance treatment with trastuzumab and pertuzumab for HER2-positive breast cancer after induction. The same list shows a 1/19/2023 accelerated approval in colorectal cancer.
atezolizumab (Tecentriq, Genentech, Inc.), October 8, with a fluoropyrimidine and oxaliplatin after surgery for Stage III mismatch repair deficient colon cancer. Drugs@FDA dates the original Tecentriq approval 05/18/2016.
nogapendekin alfa inbakicept-pmln (Anktiva), October 14, which revises the prior bladder cancer indication to include high-grade papillary-only tumors.
dostarlimab (Jemperli, GSK), October 19, for Stage II/III locally advanced rectal cancer that is MSI-H or dMMR. Its earlier accelerated approval, for dMMR solid tumors, is dated 8/17/2021.

Three of the five are for patients not yet treated for that cancer or treated after surgery: previously untreated CLL or SLL, adjuvant treatment of Stage III colon cancer, and previously untreated rectal cancer.

The October 19 roundup also lists pralsetinib (Gavreto). The FDA page it links describes an approval dated August 9, 2023, so the count here leaves it out.

How much trial evidence each approval rested on

Among the five cancer approvals and Hovilpri, four rested on randomized trials. Pirtobrutinib's BRUIN CLL-313 randomized 282 patients against bendamustine plus a rituximab product. Tucatinib's HER2CLIMB-05 was a double-blind, placebo-controlled trial of 654 patients, with median progression-free survival of 24.9 months versus 16.3 months. Atezolizumab's ATOMIC trial enrolled 711 adults and one pediatric patient, with a hazard ratio for disease-free survival of 0.50. Hovilpri (pritelivir), an antiviral, was tested against the investigator's choice of treatment in 101 immunocompromised adults; all lesions healed by 28 days in 63% of patients on Hovilpri and 34% on the other medications, the FDA said.

Two did not use a randomized trial. Dostarlimab rested on AZUR-1, a single-arm trial of 154 patients. The Anktiva expansion added no new trial: the FDA "concluded that the prior demonstration of efficacy in patients with BCG-unresponsive NMIBC containing CIS could be extrapolated to patients with BCG-unresponsive high-grade papillary disease," using the 77-patient Cohort A of QUILT-3.032 that supported the earlier indication.

One accelerated approval, and its confirmatory trial

Dostarlimab is the only accelerated approval in the set. In 116 patients evaluable by independent central review, the sustained clinical complete response at 12 months was 47% (95% CI: 27%, 56%), the FDA said. The FDA approved the application 4 months ahead of the FDA goal date, under priority review and the Commissioner's National Priority Review Voucher (CNPV) pilot program. It is the only approval page in the set that states timing against the goal date.

The condition is public. Requirement 5084-1 on the FDA list is to complete AZUR-1 (NCT05723562) "to verify and describe the clinical benefit," with an original projected completion of 7/31/2030. The registry record lists AZUR-1 as a Phase 2 study, active and not recruiting.

The same list still carries the 1/19/2023 tucatinib colorectal accelerated approval, whose confirmatory requirement had an original projected completion of 04/30/2026.

Children and rare disease

Pediatric patients appear across the month's records:

the Autus Size-Adjustable Valve, approved October 1 for pediatric patients with congenital pulmonary valve disease, can be implanted at about 13 millimeters and widened up to 22 millimeters as a child grows, the FDA said.
the atezolizumab approval covers patients two years of age and older, from a trial that enrolled one pediatric patient.
Brytly, a nonprescription eye drop from Alcon approved October 16, is for adults and children 12 years of age and older.
rare pediatric disease priority review vouchers went to Ultragenyx Pharmaceutical Inc. for FAYUVI, approved September 17, 2026, and to Ionis Pharmaceuticals, Inc. for ZANVASTRO (zilganersen), approved September 3, 2026.

On October 14 the FDA announced the Rare Disease Framework Initiative, which aims to create a fit-for-purpose framework for rare disease drug development and will gather feedback from patients, advocates and industry.

The month's non-cancer drug approvals were Hovilpri, Brytly, a generic of Climara Pro from Zydus, and Hibsago (bepirovirsen) from GSK, which the FDA called the first FDA-approved antisense oligonucleotide to treat chronic hepatitis B.

What to watch

October 28, 2026: the FDA meeting on the Rare Disease Framework Initiative at its White Oak campus.
November 2, 2026: estimated primary completion of AZUR-1 (NCT05723562), per the registry record.
November 16, 2026: nominations due for consumer representatives on FDA advisory committees.
November 20, 2026: comments due on the design of early-phase ibogaine trials.
November 30, 2026: voting-member nominations received by this date get first consideration.
7/31/2030: original projected completion of the dostarlimab confirmatory requirement, 5084-1.