Jordyn Sava

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.

Rusfertide outperformed placebo in polycythemia vera, meeting all primary and secondary end points in the phase 3 VERIFY study.

A global, randomized, phase 1b/2 trial is evaluating IO-108 in patients with metastatic and/or unresectable hepatocellular carcinoma.

In an interview, Regina Barragan-Carrillo, MD, highlighted the ongoing global disparities in renal cell carcinoma clinical trials.

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

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

IB-T101, a CD70-targeted chimeric antigen receptor therapy, is being studied for relapsed clear cell renal cell carcinoma treatment in a dose-escalation trial.

David A. Russler-Germain, MD, PhD, discusses his path in oncology and the many advancements shaping lymphoma treatment today.

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

Camizestrant combined with CDK4/6 inhibitors improved progression-free survival in HR+/HER2- advanced breast cancer with ESR1 mutations in the SERENA-6 trial.

The first patient with myelodysplastic syndrome has received iadademstat plus azacitidine in a phase 1 trial at the Medical College of Wisconsin.

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

Dosing has started in a clinical evaluating peluntamig, which targets DLL3 and CD47, combined with chemotherapy in patients with DLL3-expressing cancers.

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.

A study found that sonodynamic therapy showed no adverse events and demonstrated cancer cell death in 3 patients with glioblastoma.

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.

Gwen Nichols, MD, discussed the impact of Medicaid reductions on patient care and how oncologists can advocate for accessible cancer treatment during these uncertain times.

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.

Gwen Nichols, MD, discussed the potential implications of recent funding cuts, how they are affecting academic and community oncologists, and what may be done to mitigate the damage.

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.

A study found a 94% 6-month survival rate after tandem autologous stem cell transplant for high-risk neuroblastoma, but serious complications reduced survival.