The FDA has cleared an sNDA updating the taletrectinib (Ibtrozi) label with new DOR data in TKI-naive patients with locally advanced or metastatic ROS1-positive NSCLC.

Cesalatamig earned FDA fast track designation for NSCLC that progressed after immunotherapy and platinum-based chemotherapy.

The phase 2 AMIGO-1 trial met its end point, with an 18-month PFS rate of 66.7% for first-line amivantamab, lazertinib, and pemetrexed in EGFR-mutant NSCLC.

First-line osimertinib plus gefitinib produced an 82.1% response rate and blocked second-site EGFR resistance mutations, but missed feasibility criteria.

KST-6051 received FDA fast track designation for KRAS-mutant solid tumors.

Osimertinib plus platinum-pemetrexed showed a numerical PFS and OS advantage over osimertinib alone regardless of baseline TP53 status in FLAURA2.

The updated tarlatamab label reduces post-infusion monitoring after each of the first two doses to 6 to 8 hours, down from 22 to 24 hours.

Jay M. Lee, MD, discusses how NAUTIKA1 compares with ALNEO and LORIN, why full genomic profiling is now essential before starting chemoimmunotherapy, and how tumor boards will manage early-stage NSCLC in 5 years.