As Q1 begins, the oncology community is watching the FDA for several regulatory decisions that could introduce new treatments and imaging agents and reshape standards of care.
1. Tabelecleucel — EBV‑positive post‑transplant lymphoproliferative disease. Projected action date: January 10, 2026. Pierre Fabre resubmitted a biologics license application for tabelecleucel (Ebvallo) and received priority review. Data from more than 430 treated patients, including the phase 3 ALLELE trial, showed meaningful and durable responses. The resubmission followed resolution of manufacturing inspection issues cited in a January 2025 complete response letter; no clinical or safety deficiencies were identified.
2. 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) with chemotherapy ± bevacizumab received priority review. Phase 3 KEYNOTE‑B96/ENGOT‑ov65 results showed significant improvements in progression‑free and overall survival, with a 30% reduction in risk of progression or death in the overall population and a notable overall survival benefit in PD‑L1–positive tumors.
3. 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 the all‑oral regimen (Inqovi plus venetoclax) was accepted for review. The phase 2b ASCERTAIN‑V trial reported a complete response rate of 46.5% and a CR/CRi rate of 63.4% at a median follow‑up of 11.2 months, with durable responses across key subgroups. The submission could establish a fully oral frontline option for patients unable to receive intensive chemotherapy.
4. 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 was accepted for review. Phase 3 CONDOR data demonstrated high correct localization rates and changes in intended management for most patients with suspected recurrent disease. The new formulation is intended to increase batch size by about 50% and improve manufacturing efficiency and radioactive concentration to expand patient access.
5. Gallium‑68 edotreotide — PET imaging of somatostatin receptor‑positive neuroendocrine tumors. Projected action date: March 29, 2026. The FDA set a PDUFA target date for Lantheus’ LNTH‑2501, filed under the 505(b)(2) pathway. The application leverages an extensive evidence base supporting Ga‑68 edotreotide for SSTR‑positive NET imaging and aims to expand access to high‑quality PET imaging for adult and pediatric patients.
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