Q1 2026: 5 FDA Decisions to Watch in Oncology

The first quarter of 2026 is poised to be a significant period for oncologists and hematologists, with several high-impact FDA target action dates that could redefine standards of care in solid tumors and rare hematologic malignancies.

From the continued expansion of antibody-drug conjugates (ADCs) to the integration of immunotherapy into earlier stages of gastrointestinal disease, the following drugs represent the most critical regulatory milestones for Q1 2026.

January 2026

Tabelecleucel (Ebvallo) | BLA

• Target Action Date: January 10, 2026
• Indication: EBV-positive posttransplant lymphoproliferative disease (EBV+ PTLD)
• Clinical Context: This is an investigational, off-the-shelf, allogeneic EBV-specific T-cell immunotherapy. For patients who fail initial therapy for EBV+ PTLD—a rare but often fatal complication following hematopoietic stem cell or solid organ transplant—options are currently limited. Data from the ALLELE study(NCT03394365) reported an objective response rate (ORR) of approximately 50%, representing a potential first-in-class therapy for this orphan indication.¹

February 2026

Pembrolizumab (Keytruda) | sBLA (Priority Review)

• Target Action Date: February 20, 2026
• Indication: Platinum-resistant recurrent ovarian cancer
• Clinical Context: Ovarian cancer remains one of the most difficult-to-treat gynecologic malignancies once it becomes platinum-resistant. This application, supported by the KEYNOTE-B96 trial (NCT05116189), investigates pembrolizumab plus chemotherapy with or without bevacizumab (Avastin) in this high-unmet-need population.² While immunotherapy has traditionally struggled as a monotherapy in ovarian cancer, the FDA’s priority review designation suggests the data may offer a meaningful clinical advantage over current salvage chemotherapy.

Decitabine and Cedazuridine (Inqovi) | sNDA

• Target Action Date: February 25, 2026
• Indication: Acute myeloid leukemia (AML)
• Clinical Context: Inqovi is an oral combination of the hypomethylating agent (HMA) decitabine and the cytidine deaminase inhibitor cedazuridine. Already approved for myelodysplastic syndrome and chronic myelomonocytic leukemia, this supplemental application seeks to extend its use to AML.³ The transition from intravenous and subcutaneous HMAs to an all-oral regimen is a significant quality-of-life win for patients and reduces the infrastructure burden on infusion centers.

March 2026

Piflufolastat F 18 (Pylarify) | New Formulation NDA

• Target Action Date: March 6, 2026
• Focus: Optimized formulation for PSMA-PET imaging in prostate cancer
• Clinical Utility: This new formulation is designed to allow for larger batch sizes and wider geographic distribution. For clinicians, this means improved access to PSMA-PET imaging for high-risk patients and those with biochemical recurrence, potentially reducing wait times for critical staging scans.⁴

Gallium-68 Edotreotide (LNTH-2501) | BLA

• Target Action Date: March 29, 2026
• Indication: PET imaging of somatostatin receptor (SSTR)-positive neuroendocrine tumors (NETs).
• Clinical Utility: This diagnostic kit aims to provide a reliable and accessible tool for identifying NETs in both adult and pediatric populations, facilitating more precise surgical planning and patient selection for peptide receptor radionuclide therapy (PRRT).⁵

REFERENCES:

1. Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD). News release. Pierre Fabre Pharmaceuticals. July 25, 2025. Accessed July 25, 2025. https://tinyurl.com/2yuz9cwa

2. Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Presented at: European Society of Medical Oncology Congress 2025; October 17–20, 2025; Berlin, Germany. Abstract LBA3.

3. Taiho Oncology and Taiho Pharmaceutical Announce U.S. FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax to Treat Patients with Acute Myeloid Leukemia. News release. Taiho Oncology. July 9, 2025. Accessed December 22, 2025. https://tinyurl.com/4desm8av

4. Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent. News release. Lantheus Holdings. August 6, 2025. Accessed August 7, 2025. https://tinyurl.com/4kd65jnm

5. Lantheus Announces FDA Grants PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs). News release. Lantheus Holdings. October 30, 2025. Accessed December 22, 2025. https://tinyurl.com/4du9ufae