Nuvation Bio Gets FDA Approval for Updated IBTROZI Label

Nuvation Bio Inc, a global oncology company, has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). This approval reflects an updated median duration of response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients, marking a significant milestone for the treatment of advanced ROS1+ NSCLC.

The updated label now includes this new information, which is based on a median follow-up of 51 months for patients from the TRUST-I study. Additionally, the approval incorporates an additional 14 months of data from both the TRUST-I and TRUST-II studies, as of an August 2025 data cutoff. These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and published in the Journal of Clinical Oncology.

The approval came four months ahead of the PDUFA date, reflecting the urgency and importance of this update for patients and healthcare providers. IBTROZI is already approved for the treatment of locally advanced or metastatic ROS1+ NSCLC in the United States, Japan, and China, where it is marketed by Nippon Kayaku and Innovent Biologics, respectively. The company is also working towards full approval in Europe, with the Marketing Authorisation Application (MAA) for taletrectinib validated by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. The TRUST clinical program, which comprises three registrational studies, has evaluated the safety and efficacy of IBTROZI. TRUST-I and TRUST-II are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC, while TRUST-IV is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC.

The approval of this sNDA underscores Nuvation Bio's commitment to advancing treatment options for patients with advanced ROS1+ NSCLC. With the updated label, healthcare providers now have a clearer understanding of the long-term benefits of IBTROZI, which can help inform treatment decisions and provide patients with a more positive outlook on their condition.