FDA Actions in Oncology: April 2025 Approvals and Designations

April 2025 saw significant activity in FDA oncology news, with several notable approvals. The FDA approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for adult and pediatric patients (≥12 years) with microsatellite instability-high or mismatch repair deficient (dMMR) metastatic colorectal cancer. Additionally, larotrectinib (Vitrakvi) received full approval for patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation.

Another approval was for a new bevacizumab (Avastin) biosimilar, bevacizumab-nwgd (Jobevne), across various cancer types. Penpulimab-kcqx, in combination with chemotherapy, was also approved as a first-line treatment for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

Beyond approvals, the FDA also granted several important designations and clearances. Paige PanCancer Detect, an AI-assisted diagnostic application, received breakthrough device designation for its ability to identify various cancers across different anatomical sites. Similarly, the DAMO PANDA, an AI-powered model, earned breakthrough device designation for pancreatic cancer detection, and the EvoLiver test gained this designation for hepatocellular carcinoma surveillance in high-risk cirrhosis patients.

BCB-276, a novel chimeric antigen receptor (CAR) T-cell therapy, received breakthrough therapy designation for diffuse intrinsic pontine glioma, and iltamiocel received regenerative medicine advanced therapy designation for dysphagia following head and neck cancer treatment. The FDA also cleared several investigational new drug (IND) applications, allowing for the initiation of new clinical trials.

Finally, the FDA accepted a new drug application for ziftomenib for the treatment of adult patients with relapsed/refractory acute myeloid leukemia with NPM1 mutations and discussed the design of a phase 3 trial for darovasertib in uveal melanoma with IDEAYA Biosciences.

Here is a look back on all the FDA happenings from the month of April 2025.

FDA OKs Phase 3 Study of Linperlisib in Peripheral T-Cell Lymphoma

The FDA granted clearance to initiate a global phase 3 trial on April 1, 2025, that will evaluate linperlisib vs physicians' choice of standard of care for the treatment of relapsed/refractory peripheral T-cell lymphoma.

FDA Approves IDE Application for Alpha DaRT in Recurrent Glioblastoma

On April 2, 2025, the FDA approved an investigational device exemption application for the start of a pilot study evaluating the Alpha diffusing alpha-emitters radiation therapy technology in patients with recurrent glioblastoma.

Paige PanCancer Detect Earns FDA Designation for Multi-Tissue Cancer Detection

The FDA granted breakthrough device designation to Paige PanCancer Detect, an AI-assisted diagnostic application capable of identifying both common cancers and rare variants across diverse anatomical sites on April 3, 2025.

FDA Advances ALX2004 to Phase 1 Trials in EGFR+ Solid Tumors

On April 7, 2025, the FDA cleared the investigational new drug application for ALX2004 for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.

FDA Receives New Drug Application for Ziftomenib in NPM1-Mutant R/R AML

A new drug application seeking the approval of ziftomenib was submitted to the FDA on April 8, 2025. This indication is for the treatment of adult patients with relapsed/refractory acute myeloid leukemia harboring NMP1 mutations.

FDA Clears IND Application for ST-001 in SCLC

The FDA approved an IND application, allowing for a phase 1a/b trial of ST-001 in relapsed/refractory small cell lung cancer (SCLC), also on April 8, 2025.

FDA Approves Nivolumab/Ipilimumab Combo in MSI-H/dMMR mCRC

On April 8, 2025, the FDA also approved nivolumab plus ipilimumab as first-line therapy for adult and pediatric patients (≥12 years) with MSI high or dMMR metastatic colorectal cancer.

FDA Clears ZEISS INTRABEAM 700 for IORT in Cancer Surgery

The FDA granted 510(k) clearance to ZEISS INTRABEAM 700 on April 9, 2025, for enhanced intraoperative radiation therapy.

FDA Awards Full Approval to Larotrectinib in NTRK+ Solid Tumors

The FDA granted full approval to larotrectinib for patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation on April 10, 2025.

FDA Greenlights Bevacizumab Biosimilar Across Cancer Types

A new bevacizumab biosimilar, bevacizumab-nwgd, was approved for the treatment of various cancers, also on April 10, 2025.

FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma

On April 14, 2024, a successful Type D meeting between the FDA and IDEAYA Biosciences discussed the design of a phase 3 registrational trial evaluating darovasertib for primary uveal melanoma.

FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia

ImmunityBio has submitted a supplemental biologics license application to the FDA seeking approval for nogapendekin alfa inbakicept (Anktiva) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer, specifically for papillary disease.

FDA Grants Novel Therapy RMAT Designation for Dysphagia Following Head and Neck Cancer Treatment

Iltamiocel, an investigational cell therapy, was granted regenerative medicine advanced therapy designation by the FDA on April 15, 2025, in patients with oropharyngeal dysphagia, a common complication following treatment for head and neck cancer.

FDA Clears IND Application for CLD-201 in Solid Tumors

The FDA cleared the investigational new drug application for CLD-201 for the treatment of adult patients with solid tumors on April 17, 2025.

AI Tool Earns FDA Breakthrough Device Designation in Pancreatic Cancer

Aso on April 17, 2025, the FDA granted breakthrough device designation to the DAMO PANDA, an artificial intelligence-powered model used to detect pancreatic cancer.

Novel CAR T Therapy Earns FDA Breakthrough Status for Incurable Pediatric Brain Tumor

The FDA granted breakthrough therapy designation to BCB-276 on April 22, 2025, for the treatment of diffuse intrinsic pontine glioma, an incurable pediatric brain tumor.

FDA Clears Phase 1 Study of TGW101 for Advanced Solid Tumor Treatment

The FDA granted clearance to the investigational new drug application of TGW101 for the treatment of patients with advanced solid tumors, also on April 22, 2025.

FDA Grants Breakthrough Designation for EvoLiver in HCC

On April 23, 2025, the FDA granted breakthrough device designation to the EvoLiver test, developed by Mursla Bio, for surveillance of hepatocellular carcinoma in patients with high-risk cirrhosis.

FDA Oks Penpulimab for First-Line Non-Keratinizing Nasopharyngeal Carcinoma

Also on April 23, 2025, the FDA approved penpulimab-kcqx in combination with cisplatin or carboplatin and gemcitabine as a first-line treatment for adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.

FDA Greenlights VS-7375 Study for Tough-to-Treat KRAS G12D Tumors

The FDA cleared the IND application of VS-7375 for treatment of solid tumors on April 24, 2025.