The first quarter of 2026 will bring several high-impact FDA target action dates that could reshape care for solid tumors and rare hematologic malignancies.
January 2026: Tabelecleucel (Ebvallo) — BLA; Target action date January 10, 2026. Tabelecleucel is an off-the-shelf, allogeneic EBV-specific T‑cell immunotherapy for EBV‑positive post‑transplant lymphoproliferative disease (EBV+ PTLD). Data from the ALLELE study showed an objective response rate around 50% in patients who failed initial therapy, supporting a potential first‑in‑class option for this rare, often fatal complication after hematopoietic stem cell or solid organ transplant.
February 2026: Pembrolizumab (Keytruda) — sBLA (Priority Review); Target action date February 20, 2026. The supplemental application seeks approval of pembrolizumab plus chemotherapy, with or without bevacizumab, for platinum‑resistant recurrent ovarian cancer. The filing, supported by phase 3 data from the KEYNOTE‑B96 trial, examines whether adding immunotherapy to salvage regimens can improve outcomes in a disease setting where single‑agent immunotherapy has struggled.
February 2026: Decitabine and Cedazuridine (Inqovi) — sNDA; Target action date February 25, 2026. The supplemental filing proposes extending the oral decitabine‑cedazuridine combination to acute myeloid leukemia. Moving hypomethylating therapy from intravenous or subcutaneous administration to an all‑oral regimen could improve patient quality of life and reduce infusion‑center burden.
March 2026: Piflufolastat F 18 (Pylarify) — New formulation NDA; Target action date March 6, 2026. The new formulation is intended to support larger batch production and wider geographic distribution of the PSMA‑PET imaging agent, improving access for high‑risk prostate cancer patients and those with biochemical recurrence and potentially reducing wait times for staging scans.
March 2026: Gallium‑68 Edotreotide (LNTH‑2501) — BLA; Target action date March 29, 2026. The proposed diagnostic kit targets PET imaging of somatostatin receptor‑positive neuroendocrine tumors in adults and pediatric patients, aiming to enhance tumor detection, guide surgical planning, and refine selection of candidates for peptide receptor radionuclide therapy.
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