Nippon Kayaku obtained marketing approval for taletrectinib, licensed from Nuvation Bio, for use in unresectable, advanced or recurrent NSCLC positive for ROS1. The approval is based on the results of the TRUST-I/II trials and follows approvals in the US and China.
Nippon Kayaku announced on 19 September 2025 that it had obtained marketing approval for taletrectinib (Ibtrozi Capsules 200 mg), licensed from Nuvation Bio, for the indication of unresectable, advanced or recurrent ROS1 fusion gene-positive non-small cell lung cancer. The generic name is taletrectinib adipate, and the applicable product is Ibtrozi Capsules.
The approval is based on the results of two Phase II clinical trials, TRUST-I and TRUST-II, which reportedly demonstrated efficacy in patients, including Japanese patients, with unresectable, advanced or recurrent ROS1-positive NSCLC. This approval permits use of the treatment in Japan.
The AmoyDx Lung Cancer Multi-Gene PCR Panel has been approved as a companion diagnostic for taletrectinib. The approval of taletrectinib follows those in the US in June 2025 and China in December 2024.