As Q1 begins, the oncology community is closely watching the FDA for several key regulatory decisions that could introduce new treatment options and reshape standards of care. Below are five FDA actions to watch this quarter.
Tabelecleucel for EBV-positive post-transplant lymphoproliferative disease — projected action date January 10, 2026. Pierre Fabre resubmitted a biologics license application and the FDA granted priority review after the company resolved manufacturing inspection issues cited in a January 2025 complete response letter. Data from more than 430 treated patients, including the phase 3 ALLELE trial, showed meaningful and durable responses in adults and pediatric patients aged 2 years and older with relapsed or refractory disease who had received at least one prior therapy.
Pembrolizumab with chemotherapy, with or without bevacizumab, for platinum-resistant recurrent ovarian cancer — projected action date February 20, 2026. Merck’s supplemental BLA received priority review following results from the phase 3 KEYNOTE-B96/ENGOT-ov65 trial that showed significant improvements in progression-free survival and overall survival, including a 30% reduction in the risk of progression or death in the overall population and a notable overall survival benefit in patients with PD-L1–positive tumors.
Decitabine/cedazuridine plus venetoclax for newly diagnosed acute myeloid leukemia in patients ineligible for intensive induction chemotherapy — projected action date February 25, 2026. Taiho Oncology’s supplemental NDA was accepted based on the phase 2b ASCERTAIN-V trial, in which the all-oral regimen produced a complete response rate of 46.5% and a CR/CR with incomplete hematologic recovery rate of 63.4% at a median follow-up of 11.2 months, with durable responses across key subgroups. Approval could provide the first fully oral frontline option for this patient population.
Piflufolastat F 18 for PSMA-PET imaging in prostate cancer — projected action date March 6, 2026. Lantheus’ NDA for a new formulation was accepted; prior clinical validation from the phase 3 CONDOR trial demonstrated high correct localization rates and prompted changes in intended management for the majority of patients with suspected recurrent disease. The new formulation is expected to increase batch size by about 50% and expand access by improving manufacturing efficiency and radioactive concentration.
Gallium-68 edotreotide for PET imaging of somatostatin receptor–positive neuroendocrine tumors — projected action date March 29, 2026. The FDA set a PDUFA target date for Lantheus’ 505(b)(2) filing, which leverages an extensive published evidence base supporting Ga-68 edotreotide for SSTR-positive NET imaging. The agent aims to expand access to high-quality PET imaging to improve identification and management of patients with SSTR-positive NETs.
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