Jordyn Sava

Nicolas Girard, MD, PhD, discussed findings from the MARIPOSA and COCOON trials of amivantamab and lazertinib in EGFR+ NSCLC.

A phase 1 trial of mRNA-4106 has dosed its first patient with an advanced or metastatic solid tumor.

The FDA has approved new agents in ovarian cancer and non–small cell lung cancer and paved the way for novel antibody-drug conjugate developments.

Melphalan/hepatic delivery system showed better survival and response rates than best alternative care in metastatic uveal melanoma in the FOCUS trial.

In an interview for Melanoma Awareness Month, Andrew Pecora, MD, discussed melanoma prevention and treatment for fellow oncologists.

Samuraciclib improved progression-free survival in HR+ advanced breast cancer patients without TP53 mutations or liver metastases.

Belrestotug plus dostarlimab showed no progression-free survival benefit in NSCLC, leading GSK and iTeos to discontinue all development and ongoing trials.

The FDA granted accelerated approval to telisotuzumab vedotin for the treatment of NSCLC with high c-MET protein overexpression.

The FDA approved belzutifan as the first oral therapy for advanced or metastatic pheochromocytoma and paraganglioma in patients 12 years and older.

Colin P.N. Dinney, MD, PhD, discussed updated analyses of the BOND-003 and CORE-001 trials in bladder cancer.

Disitamab vedotin plus toripalimab showed significant survival benefits vs chemo in first-line HER2+ advanced urothelial carcinoma, with a manageable safety profile.

Durvalumab plus full BCG significantly improved disease-free survival in high-risk early bladder cancer vs BCG alone in the POTOMAC trial.

Avutometinib given with defactinib is now approved for the treatment of adult patients with recurrent low-grade serous, KRAS-positive ovarian cancer.

The FDA granted fast track status to givinostat for treating high-risk polycythemia vera, supporting its potential shown in the ongoing phase 3 GIV-IN PV trial.

Transplantation improves survival after cladribine-based therapy for patients with relapsed/refractory acute myeloid leukemia, per phase 2 trial findings.

Trials of IFx-Hu2.0 are initiating, looking to overcome checkpoint inhibitor resistance in Merkel cell carcinoma.

The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior positive feedback.

Following promising phase 1 data, ISB 2001 has gained fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma.

Mohammed Milhem, MBBS discussed the mechanism of action of RP1, the design and preliminary findings of the IGNYTE trial in melanoma.

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

The FDA requires more data to approve the application of TLX101-CDx for the detection and differentiation of glioma.

INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.

Olalekan O Oluwole, MD, MBBS, discussed a study on cytokine release syndrome and neurological events post axicabtagene ciloleucel in large B-cell lymphoma.

Adagrasib shows initial promise, tolerability, and encouraging response rates in STK11/KRAS G12C-mutant lung cancer.

Ravindra Uppaluri, MD, PhD, discussed the KEYNOTE-689 trial, which investigated pembrolizumab in locally advanced head and neck squamous cell carcinoma.

In an interview, Stacy Loeb, MD, discussed a study analyzing prostate cancer misinformation on social media.

Levee Medical has begun its pivotal ARID II trial, studying the Voro Scaffold for improved continence after prostatectomy.

The first patient has been enrolled in a trial evaluating ClarityDX Prostate’s impact on early prostate cancer detection, biopsy reduction, and healthcare efficiency.

The FDA has approved penpulimab with chemotherapy for first-line recurrent/metastatic non-keratinizing nasopharyngeal carcinoma and alone after prior treatment.