TKI Pre-treated Patients with Advanced ROS1-positive NSCLC
GSKGSKCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Zidesamtinib (NVL-520) in TKI Pre-treated Patients with Advanced ROS1-positive NSCLC. The expected timing is based on the latest available company guidance and may change.
ARROS-1 Trial. 6/24/25- Announced pivotal data. Q2 '25- Initiated rolling NDA submission & completion in Q3 2025. 11/4/25– Present patient-reported outcomes & pivotal data at IASLC ASCO'25 on Dec 6th. 10/30/25:- Completed rolling NDA submission; FDA review underway. 11/19/25- FDA accepted NDA with PDUFA date September 18, 2026. 01/12/26:- PDUFA date September 18, 2026 reaffirmed; potential first U.S. commercial launch anticipated in 2026. 02/26/26:- PDUFA September 18, 2026 reaffirmed; U.S. commercial preparations underway for TKI pre-treated ROS1-positive NSCLC. 03/17/26:- American Association for Cancer Research Apr 21 posters show ARROS-1 subset data; PDUFA Sep 18, 2026 reaffirmed. 04/21/26:- PDUFA Sep 18, 2026 reaffirmed. ARROS-1 non-NSCLC poster at ASCO May 30, 2026. 05/07/26:- ARROS-1 showed activity post repotrectinib and taletrectinib including intracranial responses; PDUFA Sep 18 2026 unchanged. Asset from Nuvalent acquisition.
Verification
Confirm timing and program details against the company announcement or filing.