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China's NMPA Approves Zai Lab's Augtyro in ROS1-Positive NSCLC

NEW YORK – Zai Lab said Monday that the National Medical Products Administration (NMPA) in China has approved its ROS1 inhibitor Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer.

The NMPA approval was based on data from the Phase I/II TRIDENT-1 study. The trial included ROS1-mutant NSCLC patients who had prior treatment with a tyrosine kinase inhibitor (TKI) and those who were TKI-naïve. In the TKI-naïve group, 79 percent of patients responded to Augtyro while among the TKI-pretreated patients, 38 percent responded to the treatment.

"There is a significant unmet need for these patients given the limited durability of benefit due to the emergence of resistance with existing therapies, eventually leading to tumor progression," Rafael Amado, president and head of global oncology research and development at Zai Lab, said in a statement.

Earlier ROS1 TKIs already on the market for NSCLC include Genentech's Rozlytrek (entrectinib) and Pfizer's Xalkori (crizotinib), along with Pfizer's second-generation ALK and ROS1 inhibitor Lorbrena (lorlatinib). However, previous research has found that about one-third of patients treated with a ROS1 inhibitor may develop acquired resistance mutations.

Zai Lab licensed Augtyro in China, Hong Kong, Macau, and Taiwan from its original developer Turning Point Therapeutics in 2020. Turning Point was later acquired by Bristol Myers Squibb, which now owns rights to Augtyro outside of these areas.

Augtyro was approved in this same setting in the US in 2023. Earlier this year, BMS also submitted an application to the US Food and Drug Administration seeking approval for the drug in adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. In August, Zai Lab said the NMPA granted breakthrough therapy designation to Augtyro for the treatment of patients with advanced solid tumors that have an NTRK gene fusion.