Jordyn Sava

Bexobrutideg, a first-in-class Bruton’s tyrosine kinase degrader, has been granted orphan drug designation from the FDA in Waldenström macroglobulinemia.

Shirish M. Gadgeel, MD, discussed long-term data from the MARIPOSA trial of lazertinib and amivantamab in EGFR-mutated non–small cell lung cancer.

Toon Van Gorp, MD, PhD, discussed findings from the MIRASOL trial and the potential of mirvetuximab to redefine treatment paradigms in ovarian cancer.

Orca-T improved 1-year survival without severe graft-vs-host disease compared with standard transplant in the Precision-T study.

The first patient has been enrolled in the PROSTATE-IQ trial of ArteraAI, a multimodal artificial intelligence biomarker test.

Jacob E. Berchuck, MD, highlights challenges in adopting liquid biopsy for PSMA expression and its potential to revolutionize precision medicine in prostate cancer.

ARC101, a potential best-in-class T-cell engager that targets solid tumors expressing CLDN6, is being assessed in a first-in-human trial.

Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.

Anthony Stein, MD, assessed total marrow and lymphoid irradiation with post-transplant cyclophosphamide in patients with acute myeloid leukemia.

177Lu rhPSMA-10.1 showed high tumor radiation with low healthy tissue exposure in a phase 1/2 trial for metastatic castration-resistant prostate cancer.

In this episode of Targeted Talks, Alfred L. Garfall, discusses the phase 2 BMT CTN 1902 trial of idecabtagene vicleucel in patients with multiple myeloma.

A phase 1 trial is evaluating Actimab-A, venetoclax, and ASTX-727 in frontline acute myeloid leukemia, with initial data expected later this year.

A real-world study showed HER2DX guided treatment changes in approximately 48% of HER2-positive breast cancer cases.

The TEDOPaM trial evaluating a novel maintenance therapy approach for advanced/metastatic pancreatic ductal adenocarcinoma has met its primary end point.

Matthew Matasar, MD, discussed what the findings from the ELM-1 trial of odronextamab in diffuse large B-cell lymphoma mean for oncologists.

The first patient was dosed in a phase 1/2 trial of evofosfamide with checkpoint inhibitors for hypoxia-reversal in resistant solid tumors.

The FDA cleared the investigational new drug application for MRANK-106, a dual WEE1/YES1 kinase inhibitor, targeting advanced solid tumors.

For Colorectal Cancer Awareness Month, Scott Kopetz, MD, PhD, FACP, discussed the BREAKWATER trial in metastatic BRAF V600E-mutated colorectal cancer.

The FDA granted orphan drug status to rhenium-186 obisbemeda for treating leptomeningeal metastases in lung cancer.

MATTERHORN is the first global phase 3 trial to show improved event-free survival with an immunotherapy combo vs standard care in this patient population.

Andrea Ledford, PharmD, MBA, BCOP, BCSCP, FASHP, FHOPA, discussed a comprehensive pharmacy program presented at the 2025 ACCC Annual Meeting & Cancer Center Business Summit.

The “off-the-shelf” CAR T-cell therapy CTD402 will be evaluated in a phase 1b/2 trial for patients with T-cell acute lymphoblastic leukemia and lymphoma.

The dose-escalation phase of the SECuRE trial in prostate cancer has completed and demonstrated promising safety and efficacy data.

Updated ASCO guidelines for pleural mesothelioma refine surgery use, recommend immunotherapy, genetic testing, and improve pathologic classification for personalized care.

The investigational immunotherapy bexmarilimab has been granted orphan drug designation from the FDA for patients with myelodysplastic syndromes.

A phase 1/2 trial is evaluating HLD-0915, a novel oral therapy, for metastatic castration-resistant prostate cancer in up to 80 patients.

Trastuzumab deruxtecan demonstrated a significant survival benefit in HER2-positive metastatic gastric cancer in the phase 3 DESTINY-Gastric04 trial.

Tislelizumab plus chemotherapy is now FDA-approved for metastatic esophageal squamous cell carcinoma with a tumor PD-L1 expression of 1 or higher.

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

Alejandro Rios Hoyo discussed findings on a subset of hormone receptor–positive, HER2-negative breast cancers classified as MP-H2.