Background on Osimertinib Resistance Mechanisms and Unmet Needs Driving Evaluation of Novel Therapies

Zongertinib is now approved by the FDA for patients with non-squamous NSCLC with HER2 TKD activating mutations.

Jacob Sands, MD, discussed considerations for EGFR-mutant non–small cell lung cancer following the approval of dato-DXd in this disease.

Nonrandomized phase 2 data support further assessment of aumolertinib among patients with NSCLC and brain metastases in a randomized clinical trial.

Stephen Liu, MD; and Joshua Sabari, MD, discuss the most intriguing non–small cell lung cancer and small cell lung cancer breakthroughs from the meeting.

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.

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.