As Q1 begins, the oncology community is watching the FDA for several decisions that could introduce new therapies and reshape standards of care. The following regulatory actions are expected this quarter.
Tabelecleucel — EBV-positive post-transplant lymphoproliferative disease. Projected action date: January 10, 2026.
Pierre Fabre resubmitted a biologics license application for tabelecleucel (Ebvallo) for adults and children aged 2 years and older with EBV-positive PTLD who have received at least one prior therapy. The FDA granted priority review after the resubmission, which followed resolution of manufacturing inspection issues cited in a January 2025 complete response letter; no clinical or safety deficiencies were identified. Data from more than 430 treated patients, including the phase 3 ALLELE trial, showed meaningful and durable responses in this population. The company said regulatory acceptance represents a key step toward the first potential FDA-approved therapy for relapsed or refractory EBV-positive PTLD.
Pembrolizumab plus chemotherapy with or without bevacizumab — platinum-resistant recurrent ovarian cancer. Projected action date: February 20, 2026.
Merck’s supplemental BLA for pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab (Avastin), was granted priority review. Results from the phase 3 KEYNOTE-B96/ENGOT-ov65 trial showed a significant improvement in progression-free survival and overall survival, including a 30% reduction in the risk of progression or death in the overall population and a meaningful OS benefit in patients with PD-L1–positive tumors. Merck noted this could be the first immunotherapy to demonstrate an overall survival benefit in certain patients with platinum-resistant recurrent ovarian cancer.
Decitabine/cedazuridine plus venetoclax — newly diagnosed acute myeloid leukemia in patients ineligible for intensive induction chemotherapy. Projected action date: February 25, 2026.
Taiho Oncology’s supplemental NDA for an all-oral regimen of decitabine/cedazuridine (Inqovi) combined with venetoclax (Venclexta) was accepted for review. In the phase 2b ASCERTAIN-V trial, the 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. The filing, presented at the 2025 ASCO Annual Meeting and EHA Congress, could bring the first fully oral frontline option for patients unable to receive intensive chemotherapy.
Piflufolastat F 18 — PSMA-PET imaging in prostate cancer. Projected action date: March 6, 2026.
Lantheus’ NDA for a new formulation of piflufolastat F 18, a PSMA-targeted PET imaging agent, was accepted for review. 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 patient access by improving manufacturing efficiency and radioactive concentration.
Gallium-68 edotreotide (LNTH-2501) — PET imaging of somatostatin receptor–positive neuroendocrine tumors. Projected action date: March 29, 2026.
The FDA established a PDUFA target action date for Lantheus’ gallium-68 edotreotide, submitted under the 505(b)(2) pathway for imaging of SSTR-positive NETs in adults and children. The application leverages an extensive published evidence base supporting Ga-68 edotreotide for SSTR imaging. The company says LNTH-2501 is intended to expand access to reliable, high-quality PET imaging to improve identification and management of patients with SSTR-positive neuroendocrine tumors.
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