FDA Approvals & Designations in Oncology: February 2025 Highlights

US FDA

In February 2025, the FDA issued several key approvals and designations across oncology, offering new hope and advanced therapeutic options for patients with various cancers.

Highlights include the acceptance of a biologics license application for HLX11, a pertuzumab (Perjeta) biosimilar for HER2-positive breast cancer, and the approval of mirdametinib (formerly PD-0325901) for neurofibromatosis type 1-associated plexiform neurofibromas.

The FDA also granted Regenerative Medicine Advanced Therapy designations to gemogenovatucel-T (Vigil) for advanced ovarian cancer and NXC-201 for relapsed/refractory light chain amyloidosis.

In lung cancer, zongertinib (BI 1810631) received priority review for HER2-mutant non–small cell lung cancer, while IBI363 and Serial CTRS, an artificial intelligence (AI) prognostic tool, earned fast track and breakthrough designations.

For hematologic malignancies, brentuximab vedotin (Adcetris) was approved in a triplet regimen for relapsed/refractory large B-cell lymphoma, and odronextamab’s (Ordspono) biologics license application was accepted for follicular lymphoma.

Additionally, vimseltinib (DCC-3014) gained approval for tenosynovial giant cell tumor, and dordaviprone (ONC201) received priority review for H3K27M-mutant diffuse glioma.

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

FDA Considers BLA for Pertuzumab Biosimilar HLX11 in Breast Cancer

On February 2, 2025, the FDA accepted for review a biologics license application seeking the approval of HLX11 for the treatment of select patients with HER2-positive breast cancer.

FDA Grants Gemogenovatucel-T RMAT Status in Advanced Ovarian Cancer

The FDA granted regenerative medicine advanced therapy (RMAT) designation to gemogenovatucel-T (Vigil) on February 5, 2025, for its use as a maintenance treatment for newly diagnosed, advanced stage IIIB/IV ovarian cancer patients who are homologous recombination proficient, have high clonal tumor mutational burden, and are in complete response following debulking surgery and frontline platinum-based chemotherapy.

FDA Grants ²²⁵Ac-SSO110 Orphan Drug Status in SCLC

The FDA granted orphan drug designation to ²²⁵Ac-SSO110 (satoreotide) for the treatment of patients with small cell lung cancer, on February 6, 2025.

AI Prognostic Tool for NSCLC Earns FDA Breakthrough Designation

Also on February 6, 2025, the FDA granted breakthrough device designation to Serial CTRS, an AI–based prognostic tool that aims to stratify patients with non–small cell lung cancer into high- or low-risk mortality categories.

Microscopic view of a cancer cell being destroyed by a targeted therapy treatment, representing the latest advancements in medical research towards a cancer cure: © Sirinporn - stock.adobe.com

FDA Grants 510(k) Clearance to Ibex Prostate Detect AI for Prostate Cancer

On February 10, 2025, the FDA granted a 510(k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read).

FDA Fast Tracks Amezalpat for HCC Treatment

The FDA granted fast track designation to amezalpat (TPST-1120) for the potential treatment of patients with hepatocellular carcinoma, also on February 10, 2025.

NXC-201 Earns FDA RMAT Designation in AL Amyloidosis

On February 10, 2025, the FDA also granted Regenerative Medicine Advanced Therapy designation to NXC-201 for the treatment of relapsed or refractory light chain amyloidosis.

FDA Reviews Linvoseltamab in Relapsed/Refractory Multiple Myeloma

The FDA accepted the resubmitted biologics license application (BLA) for linvoseltamab (REGN5458) on February 11, 2025, for the treatment of heavily pretreated adults with relapsed/refractory multiple myeloma.

FDA Greenlights Mirdametinib in Adult and Pediatric NF1-PN

Also on February 11 2025, the FDA approved mirdametinib (formerly PD-0325901) in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

FDA Approves Brentuximab Vedotin Triplet in R/R Large B-cell Lymphoma

The FDA also approved the combination of brentuximab vedotin (Adcetris), lenalidomide (Revlimid) and rituximab (Rituxan) for adult patients with relapsed/refractory large B-cell lymphoma on February 11, 2025.

FDA Fast Tracks CUSP06 in Platinum-Resistant Ovarian Cancer

The FDA granted fast track designation to CUSP06 on February 12, 2025, for the treatment of patients with platinum-resistant ovarian cancer.

FDA Grants OPN-6602 Orphan Drug Status in R/R Myeloma

The FDA granted orphan drug designation to OPN-6602 for the treatment of patients with relapsed/refractory multiple myeloma, also on February 12, 2025.

Vimseltinib Gains FDA Approval in Tenosynovial Giant Cell Tumor

The FDA approved vimseltinib (DCC-3014) for the treatment of symptomatic tenosynovial giant cell tumor on February 14, 2025.

Cancer cells with pink bubbles: © Adobe Contributor - stock.adobe.comNormal

FDA Fast-Tracks IBI363 in Squamous NSCLC

The FDA granted fast track designation to IBI363 on February 17, 2025, for the treatment of patients with unresectable, locally advanced, or metastatic squamous non–small cell lung cancer.

FDA Gives Dordaviprone Priority Review in H3K27M-Mutant Diffuse Glioma

On February 18, 2025, the FDA accepted and granted priority review to a new drug application for the accelerated approval of dordaviprone (ONC201) for the treatment of patients with recurrent H3K27M-mutant diffuse glioma.

FDA Grants Breakthrough Therapy Status to Petosemtamab/Pembrolizumab in HNSCC

Also on February 18, 2025, the FDA granted breakthrough therapy designation to the combination of petosemtamab plus pembrolizumab (Keytruda) as a first-line treatment for adult patients with recurrent or metastatic head and neck squamous cell carcinoma with a PD-L1 combined positive score of at least 1.

FDA Grants Priority Review to Zongertinib in HER2-Mutant NSCLC

The FDA accepted and granted priority review to the new drug application for zongertinib (BI 1810631) for treating patients with unresectable or metastatic non–small cell lung cancer harboring HER2 (ERBB2) mutations who have undergone prior systemic therapy on February 19, 2025.

FDA Grants Fast Track Designation to ⁶⁷Cu-SAR-bisPSMA in mCRPC

The FDA also granted fast track designation to ⁶⁷Cu-SAR-bisPSMA for treating adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been previously treated with androgen receptor pathway inhibition on February 19, 2025.

FDA Accepts sBLA for Nivolumab/Ipilimumab Combo in dMMR/MSI-H CRC

On February 24, 2025, the FDA accepted the supplemental biologics license application for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as a potential first-line treatment option for adult and pediatric patients aged 12 years and older with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma

The FDA cleared the investigational new drug application for LTZ-301 as a potential treatment for patients with relapsed or refractory non-Hodgkin lymphoma, also on February 24, 2025.

FDA Fast-Tracks AUTX-703 in Relapsed/Refractory AML

The FDA also granted fast track designation to AUTX-703 on February 24, 2025, for the treatment of patients with relapsed/refractory acute myelogenous leukemia.

FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC

On February 25, 2025, the FDA accepted and granted priority review to a supplemental biologics license application for pembrolizumab (Keytruda).

FDA Accepts Odronextamab BLA in Relapsed/Refractory Follicular Lymphoma

The FDA accepted resubmission of the biologics license application of odronextamab (Ordspono) for review for treating relapsed/refractory follicular lymphoma after at least 2 lines of systemic therapy on February 26, 2025.

FDA Grants PYX-201 Fast Track Status in HNSCC

Also on February 26, 2025, the FDA granted fast track designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma.

FDA Clears IND for Phase 1 Trial of ADCE-T02 in Solid Tumors

The FDA cleared the investigational new drug application for a phase 1 trial of ADCE-T02 on February 26, 2025, for the treatment of patients with advanced solid tumors.

FDA Grants RMAT Designation to Nogapendekin Alfa in Pancreatic Cancer

On February 27, 2025, the FDA granted Regenerative Medicine Advanced Therapy status to nogapendekin alfa (Anktiva) and CAR-NK (PD-L1 t-haNK) for reversing lymphopenia in patients undergoing chemotherapy/radiotherapy and treating metastatic pancreatic cancer.

FDA Grants Priority Review to TLX250-CDx in Kidney Cancer

The FDA accepted and granted priority review to the biologics license application of TLX250-CDx (Zircaix, ⁸⁹Zr-DFO-girentuximab) for the treatment of clear cell renal cell carcinoma on February 28, 2025.