FDA Oncology Actions: March 2025 Approvals and Designations

In March 2025, the FDA made significant strides in oncology, approving a number of agents across cancer types. The FDA started off the month approving 2 denosumab biosimilars, denosumab-bmwo (CT-P41; Stoboclo) and Osenvelt, expanding treatment options for osteoporosis-related fractures and cancer-related skeletal events. Additionally, tislelizumab (Tevimbra) plus chemotherapy was approved for frontline treatment of advanced esophageal squamous cell carcinoma with high PD-L1 expression, and cabozantinib (Cabometyx) was approved for advanced neuroendocrine tumors.

Pembrolizumab (Keytruda) plus trastuzumab (Herceptin) and chemotherapy received standard approval for HER2-positive, PD-L1–positive gastric cancer, while lutetium-177 (¹⁷⁷Lu) vipivotide tetraxetan (¹⁷⁷Lu PSMA-617; Pluvicto) gained an expanded indication for metastatic castration-resistant prostate cancer. Finally, durvalumab (Imfinzi) was approved for muscle-invasive bladder cancer.

The FDA also granted several orphan drug designations, including bexmarilimab for myelodysplastic syndromes, rhenium (186Re) obisbemeda for leptomeningeal metastases in lung cancer, and bexobrutideg (NX-5948) for Waldenström macroglobulinemia.

Numerous investigational new drug (IND) applications were also cleared by the FDA, including for the chimeric antigen receptor (CAR) T-cell therapy CTD402 for T-cell acute lymphoblastic leukemia/lymphoma and MRANK-106, a dual WEE1/YES1 kinase inhibitor, for advanced solid tumors. The agency also cleared an IND application for EVM14, a tumor-associated antigen vaccine, to treat various cancers.

Here is a look back at all the FDA happenings from the month of March 2025.

Two Denosumab Biosimilars Pocket FDA Approval in Multiple Indications

On March 3, 2025, the FDA approved 2 biosimilars, denosumab-bmwo (CT-P41; Stoboclo) and (Osenvelt), for all indications of their respective reference products (Prolia) and (Xgeva). These indications include osteoporosis-related fractures and cancer-related skeletal events in both men and women across cancer types.

FDA Grants Bexmarilimab Orphan Drug Designation for MDS

The FDA also granted bexmarilimab orphan drug designation for the potential treatment of patients with myelodysplastic syndromes on March 3, 2025.

FDA Approves Frontline Tislelizumab Plus Chemotherapy in Advanced ESCC

On March 4, 2025, the FDA approved tislelizumab-jsgr (Tevimbra) and platinum-containing chemotherapy for the frontline treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma with a tumor PD-L1 expression of 1 or higher.

FDA OKs Trial of Novel CAR T-Cell Therapy in T-ALL/LBL

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma.

FDA Grants Rhenium Obisbemeda Orphan Drug Status for LM in Lung Cancer

The FDA granted orphan drug designation to rhenium (186Re) obisbemeda on March 6, 2025, for the potential treatment of patients with leptomeningeal metastases in patients with lung cancer.

FDA Clears Phase 1 Trial of MRANK-106 in Advanced Solid Tumors

The FDA cleared the investigational new drug application for MRANK-106, a first-in-class dual WEE1/YES1 kinase inhibitor for advanced solid tumors on March 7, 2025.

Bexobrutideg Gains FDA Orphan Drug Status in Waldenström Macroglobulinemia

On March 17, 2025, the FDA granted bexobrutideg (NX-5948) orphan drug designation for the treatment of patients with Waldenström macroglobulinemia.

FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer

On March 17, 2025, the FDA also granted an orphan drug designation to PEP-010 for the treatment of patients with metastatic pancreatic cancer.

FDA Backs Phase 3 Trial of Pro-ocular for Ocular GVHD Treatment

It was announced on March 18, 2025, that Signal12 Pharmaceuticals aligned with the FDA on its phase 3 clinical trial strategy for Pro-ocular, a novel drop-free therapy for ocular graft-vs-host disease.

FDA Grants Orphan Drug Designation to HLX22 for Gastric Cancer Treatment

The FDA granted orphan drug designation on March 19, 2025, to HLX22 for the treatment of patients with gastric cancer.

FDA Grants Standard Approval to Pembrolizumab Plus Trastuzumab/Chemo for HER2+, PD-L1+ Gastric Cancer

Also on March 19, 2025, the FDA granted standard approval to pembrolizumab (Keytruda) plus trastuzumab (Herceptin) and chemotherapy for the treatment of patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Azer-Cel Fast Track Status in DLBCL

The FDA also granted fast track designation to azercabtagene zapreleucel (azer-cel; PBCAR0191) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma on March 19, 2025.

FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer

The FDA extended the review period for its De Novo marketing authorization request for the ProSense cryoablation system on March 20, 2025.

FDA Clears IND Application for EVM14 Across Cancers

On March 23, 2025, the FDA cleared the investigational new drug application for EVM14, an off-the-shelf tumor-associated antigen vaccine designed to treat various cancers, including non–small cell lung cancer and head and neck cancer.

FDA Backs Phase 3 Study of IMNN-001 in Advanced Ovarian Cancer

On March 24, 2025, the FDA-aligned with a protocol to evaluate IMNN-001 with neoadjuvant chemotherapy (NACT) vs NACT alone, with overall survival as the primary end point.

FDA Approves Cabozantinib for Advanced Neuroendocrine Tumors

The FDA approved cabozantinib (Cabometyx) for advanced neuroendocrine cancers on March 26, 2025.

Leronlimab Gets FDA Nod for Phase 2 Microsatellite-Stable CRC Trial

The FDA granted clearance for the start of a phase 2 study (NCT06699835) evaluating leronlimab in patients with relapsed/refractory microsatellite stable metastatic colorectal cancer on March 27, 2025.

FDA Expands Indication for Lutetium-177 PSMA-617 in PSMA-Positive mCRPC

The FDA expanded the indication for ¹⁷⁷Lu PSMA-617 (Pluvicto) on March 28, 2025. The approval now includes adults with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.

FDA Grants Approval to Durvalumab in MIBC

Durvalumab (Imfinzi) was approved by the FDA on March 28, 2025, for the treatment of patients with muscle-invasive bladder cancer.

FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma

The FDA granted breakthrough therapy designation to darovasertib as a neoadjuvant treatment for adult patients with primary uveal melanoma on March 31, 2025.

FDA Clears IND Application for CER-1236 in Advanced Solid Tumors

Also on March 31, 2025, the FDA cleared a second investigational new drug application for CER-1236 in advanced solid tumors.