Q1 2026: 5 FDA Decisions to Watch in the Realm of Oncology

As Q1 begins, the oncology community is closely watching the FDA for several key regulatory decisions. With potential approvals spanning a range of therapeutic areas, the next few months could introduce new treatment options and reshape current standards of care.

Here is OncLive®’s curated list of FDA decisions to watch this quarter.

#1: Tabelecleucel

Drug Indication: EBV+ Post-Transplant Lymphoproliferative Disease
Projected Action Date: January 10, 2026

On July 24, 2025, Pierre Fabre Laboratories announced that the FDA granted priority review to a resubmitted biologics license application (BLA) seeking approval of tabelecleucel (Ebvallo) for use in adult and pediatric patients aged 2 years and older with Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease (PTLD) who have received at least 1 prior therapy.¹ Based on findings from more than 430 treated patients, including the phase 3 ALLELE trial (NCT03394365), tabelecleucel demonstrated meaningful and durable responses in this population. The resubmission follows resolution of manufacturing inspection issues cited in a January 2025 complete response letter,² with no clinical or safety deficiencies identified.

According to a Pierre Fabre news release, regulatory acceptance of the BLA for review represents a critical step toward bringing the first potential FDA-approved therapy to patients with relapsed or refractory EBV-positive PTLD, whose survival after treatment failure is often measured in weeks to months.

#2: Pembrolizumab Plus Chemo ± Bevacizumab

Drug Indication: Platinum-Resistant Recurrent Ovarian Cancer
Projected Action Date: February 20, 2026

On October 18, 2025, Merck announced that the FDA granted priority review to a supplemental biologics license application (sBLA) seeking approval of pembrolizumab (Keytruda) in combination with chemotherapy with or without bevacizumab (Avastin) for patients with platinum-resistant recurrent ovarian cancer. Based on data from the phase 3 KEYNOTE-B96/ENGOT-ov65 trial (NCT05116189), the regimen significantly improved progression-free survival and overall survival (OS), reducing the risk of disease progression or death by 30% in the overall population and demonstrating a meaningful OS benefit in patients with PD-L1–positive tumors.³

According to a Merck news release, this application is notable as pembrolizumab represents the first immunotherapy to demonstrate an OS benefit in certain patients with platinum-resistant recurrent ovarian cancer, a setting with historically limited treatment options.

#3: Decitabine/Cedazuridine Plus Venetoclax

Drug Indication: Newly Diagnosed AML
Projected Action Date: February 25, 2026

On July 9, 2025, Taiho Oncology announced that the FDA accepted for review a supplemental new drug application (NDA) for decitabine and cedazuridine (Inqovi) plus venetoclax (Venclexta) for adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.⁴ Based on findings from the phase 2b ASCERTAIN-V trial (NCT04657081), the all-oral regimen achieved a complete response (CR) rate of 46.5% and a complete response (CR)/CR with incomplete hematologic recovery rate of 63.4% at a median follow-up of 11.2 months, with durable responses observed across key subgroups. The submission follows presentations of the data at the 2025 ASCO Annual Meeting and the 2025 EHA Congress.

According to a Taiho Oncology news release, this application is significant because it could introduce the first fully oral frontline treatment option for patients with AML who are unable to receive intensive chemotherapy.

#4: Piflufolastat F 18

Indication: PSMA-PET Imaging in Prostate Cancer
Projected Action Date: March 6, 2026

On August 6, 2025, Lantheus announced that the FDA accepted an NDA for a new formulation of the prostate-specific membrane antigen PET imaging agent piflufolastat F 18 for use in patients with prostate cancer.⁵ Based on prior clinical validation from the phase 3 CONDOR trial (NCT03739684), piflufolastat F 18 demonstrated high correct localization rates and led to changes in intended management for the majority of imaged patients with suspected recurrent disease.

According to a Lantheus news release, the new formulation is expected to increase batch size by approximately 50% and expand patient access by improving manufacturing efficiency and radioactive concentration.

#5: Gallium-68 Edotreotide

Indication: PET Imaging of Somatostatin Receptor–Positive Neuroendocrine Tumors
Projected Action Date: March 29, 2026

On October 30, 2025, Lantheus announced that the FDA established a Prescription Drug User Fee Act (PDUFA) target action date for gallium-68 edotreotide (LNTH-2501) for PET imaging of somatostatin receptor (SSTR)–positive neuroendocrine tumors (NETs) in adult and pediatric patients. Based on an application submitted under the 505(b)(2) pathway, the filing leverages an extensive published evidence base supporting Ga-68 edotreotide for SSTR-positive NETs imaging.

According to a Lantheus news release, LNTH-2501 is designed to expand access to reliable, high-quality PET imaging to improve identification and management of patients with SSTR-positive NETs.

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 24, 2025. Accessed January 5, 2026. https://www.prnewswire.com/news-releases/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-disea-302513152.html
2. Atara Biotherapeutics provides regulatory and business update on EBVALLO (tabelecleucel). News release. Atara Biotherapeutics. January 16, 2025. Accessed January 5, 2026. https://investors.atarabio.com/news-events/press-releases/detail/367/atara-biotherapeutics-provides-regulatory-and-business
3. KEYTRUDA (pembrolizumab) plus chemotherapy with or without bevacizumab reduced risk of disease progression or death versus chemotherapy with or without bevacizumab in certain patients with platinum-resistant recurrent ovarian cancer. News release. Merck. October 18, 2025. Accessed January 5, 2026. https://www.merck.com/news/keytruda-pembrolizumab-plus-chemotherapy-with-or-without-bevacizumab-reduced-risk-of-disease-progression-or-death-versus-chemotherapy-with-or-without-bevacizumab-in-certain-patients-with-plati
4. 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, Inc., and Taiho Pharmaceutical Co., Ltd. July 9, 2025. Accessed January 5, 2026. https://www.taihooncology.com/us/news/taiho-oncology-and-taiho-pharmaceutical-announce-us-fda-acceptance-of-supplemental-new-drug-application-for-inqovi-in-combination-with-venetoclax-to-treat-patients-with-acute-myeloid-leukemia/
5. Lantheus announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. Lantheus. August 6, 2025. Accessed January 5, 2026. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-nda-new-formulation-market