News|Articles|March 4, 2025
FDA Approvals & Designations in Oncology: February 2025 Highlights
Author(s)Jordyn Sava
Fact checked by: Jason M. Broderick
Here is a look back on all the FDA happenings from the month of February 2025.
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.
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.
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.
The FDA granted orphan drug designation to 225Ac-SSO110 (satoreotide) for the treatment of patients with small cell lung cancer, on February 6, 2025.
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.
On February 10, 2025, the FDA granted a 510(k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read).
The FDA granted fast track designation to amezalpat (TPST-1120) for the potential treatment of patients with hepatocellular carcinoma, also on February 10, 2025.
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.
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.
Also on February 11 2025, the FDA approved mirdametinib (formerly PD-0325901) in adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.
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.
The FDA granted fast track designation to CUSP06 on February 12, 2025, for the treatment of patients with platinum-resistant ovarian cancer.
The FDA granted orphan drug designation to OPN-6602 for the treatment of patients with relapsed/refractory multiple myeloma, also on February 12, 2025.
The FDA approved vimseltinib (DCC-3014) for the treatment of symptomatic tenosynovial giant cell tumor on February 14, 2025.
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.
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.
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.
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.
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.
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.
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.
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.
On February 25, 2025, the FDA accepted and granted priority review to a supplemental biologics license application for pembrolizumab (Keytruda).
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.
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.
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.
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.
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.
Related Content
Advertisement
