FDA Approves Priority Review of Merck's Zolinza (Vorinostat)

A genitourinary oncologist explained that KIM-1 can be used diagnose, risk-stratify, detect, and monitor disease treatment in patients with kidney cancers.

Leading experts in the breast cancer field highlight the use of CDK4/6 inhibitors, antibody-drug conjugates, and other treatment modalities.

The agency’s decision is based on results from the phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with solid tumors.

According to Jorge Nieva, MD, taletrectinib may be a primary frontline therapy option for those with ROS1-positive non–small cell lung cancer.

Data from the phase 3 INAVO120 trial support the approval of inavolisib-based treatment for patients with PIK3CA+, ER+/HER2– disease in the EU.

Support for the regulatory decision follows data from a phase 1/2a clinical trial assessing the agent in EGFR-mutant NSCLC at the 2025 ASCO Annual Meeting.