Nuvation Bio updates IBTROZI FDA label

• Nuvation Bio (NASDAQ:NUVB) received FDA approval for a supplemental New Drug Application updating IBTROZI efficacy data.
• The U.S. label now includes a 49.7-month median duration of response in TKI-naïve ROS1-positive NSCLC patients.
• The FDA approved the update four months ahead of the PDUFA date without changes to the safety sections.

Nuvation Bio (NASDAQ:NUVB) received U.S. Food and Drug Administration approval for a supplemental New Drug Application updating efficacy information for IBTROZI (taletrectinib) in TKI-naïve adults with advanced ROS1-positive non-small cell lung cancer.

The updated U.S. prescribing information includes a median duration of response of 49.7 months in TKI-naïve patients from the Phase 2 TRUST-I study, based on a median follow-up of 51 months and additional data from TRUST-I and TRUST-II.

The FDA approved the label update four months ahead of the PDUFA date, with no changes made to the safety sections of the label and no new safety signals identified.

Nuvation Bio develops targeted cancer therapies, including IBTROZI, which is designed for patients with ROS1-positive non-small cell lung cancer.

IBTROZI received full FDA approval in June 2025 for adults with locally advanced or metastatic ROS1-positive NSCLC and is also approved in Japan and China, while marketing applications remain under review by the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency.