Nuvation Bio has announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC) with a target action date of January 4, 2027.

The submission, which fulfills an FDA post-marketing commitment and is intended to update the efficacy information provided in the IBTROZI label, includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up.

As of this data cutoff, IBTROZI demonstrated median Duration of Response (mDOR) of 49.7 months and median Progression-Free Survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I, reflecting over four years of sustained clinical benefit, and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II.

In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data cutoff and is subject to change as the data mature. Importantly, the safety profile remained consistent with prior reports, and no new signals were identified. Many patients remained on therapy for extended periods and without disease progression—some for multiple years—highlighting the long-term tolerability of IBTROZI and reinforcing its importance as a treatment option. These data were recently presented at the American Association for Cancer Research (AACR) Annual Meeting 2026.

David Hung, MD, Founder, President, and Chief Executive Officer (CEO), Nuvation Bio, said, "These longer-term data for IBTROZI—which show an impressive median duration of response of more than four years in TKI-naïve patients, mirrored by the Progression-Free Survival results and supported by a consistent safety profile—reinforce our belief that IBTROZI is becoming the new standard of care in advanced ROS1+ NSCLC. The breadth and maturity of these data give both patients and providers even greater confidence when selecting IBTROZI."

The US FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, followed by a successful launch. 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.