February 2025 Brief

FDA reviews biologics license application for HLX11, a biosimilar to pertuzumab, for HER2-positive breast cancer.

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its prior HER2-low indication.

The FDA granted RMAT status to gemogenovatucel-T for maintenance in patients with advanced ovarian cancer.

225Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment of SCLC.

The FDA granted breakthrough status to Serial CTRS, an AI tool that improves survival predictions in non–small cell lung cancer.

The FDA cleared Ibex Prostate Detect, an artificial intelligence tool aiding prostate cancer detection.

Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.

The FDA has accepted the resubmitted biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma in heavily pretreated adults.

The FDA approved mirdametinib for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

The FDA approved brentuximab vedotin, lenalidomide, and rituximab for large B-cell lymphoma after 2 therapies in patients ineligible for transplant or chimeric antigen receptor T-cell therapy.

Vimseltinib is now an FDA-approved treatment for patients with tenosynovial giant cell tumor, based on findings from the phase 3 MOTION trial.

The FDA granted orphan drug designation to OPN-6602 for the potential treatment of relapsed/refractory multiple myeloma.

The FDA granted Regenerative Medicine Advanced Therapy designation to NXC-201 for the treatment of relapsed/refractory light chain amyloidosis.

The FDA granted fast track status to IBI363 for the treatment of patients with advanced squamous lung cancer after prior treatment.

The FDA has granted a priority review to dordaviprone for treating patients with recurrent H3K27M-mutant diffuse glioma, a population with limited treatment options.

Based on data from the Beamion LUNG-1 trial, the FDA granted a priority review to zongertinib for patients with HER2-mutant advanced non–small cell lung cancer.

The FDA granted breakthrough therapy status to first-line petosemtamab plus pembrolizumab for PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has granted fast track status to 67Cu-SAR-bisPSMA for metastatic prostate cancer that is resistant to hormone therapy after prior treatment, based on SECuRE trial data.

Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a decision expected by June 2025.

The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a phase 1 study set for mid-2025.

The FDA has granted AUTX-703, a first-in-class oral KAT2A/B degrader, fast track designation for the treatment of relapsed/refractory acute myelogenous leukemia.

The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, based on KEYNOTE-689 trial data.

The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after phase 3 trial enrollment milestone.

PYX-201 has gained FDA fast track designation in recurrent or metastatic head and neck squamous cell carcinoma.

The FDA approved the investigational new drug application for a phase 1 trial of ADCE-T02 in advanced solid tumors.

The FDA granted RMAT designation to nogapendekin alfa and CAR-NK for reversing lymphopenia in patients with cancer, with promising survival data in metastatic pancreatic cancer and non–small cell lung cancer.

The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, 2025.

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