Nuvation Bio has announced that the US 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).

The updated IBTROZI label now reflects updated median Duration of Response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients in TRUST-I, reflecting over 4 years of sustained clinical benefit. This update came with no changes to the safety sections of labeling, with no new signals identified with longer follow-up, confirming the safety profile.

The sNDA approval reflects a median follow-up of 51 months for patients from the TRUST-I study and incorporates an additional 14 months of data from both of the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff. Many patients remained on therapy for extended periods with a continued response—some for multiple years—highlighting the long-term durability and tolerability of IBTROZI and reinforcing its importance as a treatment option for advanced ROS1+ NSCLC. These data were also presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and simultaneously published in the Journal of Clinical Oncology.

David Hung, MD, Founder, President, and Chief Executive Officer, Nuvation Bio, said, "This approval is a significant milestone for IBTROZI because this data is now part of the FDA-approved label, something physicians and patients can turn to directly. A median duration of response of more than four years—the longest median DOR reported for an FDA-approved ROS1 TKI—is a remarkable outcome for people living with ROS1+ NSCLC, and having it in the label means something real for patients: a clearer sense of how long they might expect to stay on treatment, and more confidence in what that path could look like at a moment when a new diagnosis can feel overwhelming. It also gives physicians additional evidence to support using IBTROZI early in a patient's care, when that choice matters most."

The FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

Additionally, the company, along with its partner, Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency (EMA) for full approval consideration with a standard review timeline, and in June 2026 that the MAA was validated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.