Dr Florez on the FDA Approval of Zidesamtinib in Pretreated ROS1+ NSCLC

“Right when Dr Velcheti was presenting on ROS1 is when the drug was approved, so his presentation was already out of date, and that’s what is so important about the Bridging the Gaps [meetings].”

Narjust Florez, MD,associate medical director of the Cancer Care Access Program and a thoracic medical oncologist at Dana-Farber Cancer Institute, discussedthe rapidly evolving treatment landscape in ROS1-positive non–small cell lung cancer (NSCLC) and the challenges this pace of change poses for guiding clinical decisions during the Bridging the Gaps (BTG) in Lung Cancer meeting.

On July 22, 2026, the FDA approved zidesamtinib (Jideytro) for adult patients with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor.Florez noted that the recent approval of this agent brings improved tolerability to the space, though she pointed out that another available option, taletrectinib (Ibtrozi), is also well tolerated. She observed the irony that ROS1-positive NSCLC, a relatively rare entity, now has an increasingly crowded treatment landscape.

Florez also highlighted a broader challenge tied to this rapid pace: a presentation on the ROS1-positive landscape, delivered by Vamsi Velcheti, MD, of Mayo Clinic, during the BTG meeting, was already outdated by the time it was given, since the newest approval came through while he was on the stage. She said this underscores exactly why meetings like BTG are valuable, as they surface these emerging gaps in real time.

Florez explained that while the latest approval offers a more tolerable option, an important unresolved question remains: should it be used in the first-line or second-line setting? With so many treatment options now available for ROS1-positive NSCLC, she said, determining the optimal sequence and treatment of choice remains a significant gap in the field.