Jordyn Sava

Hany Elmariah, MD, discussed the safety profile of fedratinib and its evolving role in the post-transplant setting for patients with myeloproliferative neoplasms.

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.

The FORTIFI-HN01 trial has begun enrolling patients with advanced head and neck cancer to evaluate ficerafusp alfa plus pembrolizumab as a first-line therapy.

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 CRISTALLO trial showed that venetoclax plus obinutuzumab achieved high minimal residual disease negativity as a frontline chronic lymphocytic leukemia therapy.

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

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

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

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

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

Anakinra failed to reduce cytokine release syndrome or immune effector cell–associated neurotoxicity in patients with large B-cell lymphoma receiving liso-cel.

Talazoparib plus enzalutamide boosts overall survival in metastatic castration-resistant prostate cancer, with HRR-deficient patients seeing a 14-month gain and 38% lower death risk.

As the 2025 ASCO Genitourinary Cancers Symposium approaches, several highly anticipated studies are set to shape the future of treatment for prostate, kidney, bladder, and other genitourinary cancers.

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.

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

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

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

The phase 3 waveLINE-010 trial is evaluating zilovertamab vedotin plus R-CHP vs R-CHOP for the treatment of untreated diffuse large B-cell lymphoma.

William Dale, MD, PhD, FASCO, highlighted the shift from the first geriatric oncology guidelines made in 2018 to the advancements that are shaping the field today.

This approach aims to improve treatment for patients with this highly aggressive and treatment-resistant type of breast cancer.

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

In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan in breast cancer.

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

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

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

Andrea Roman, PharmD, BCOP, US Oncology Network and McKesson, discussed the integration of clinical pharmacists into community oncology practices.