Zai Lab has announced that its New Drug Application (NDA) for Augtyro (repotrectinib) has been greenlit by China’s National Medical Products Administration (NMPA) for use in the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Augtyro, an orally administered tyrosine kinase inhibitor (TKI) designed to inhibit specific kinases and block further disease progression and tumour growth, is being evaluated in the Phase I/II TRIDENT-1 study (NCT03093116) by Turning Point Therapeutics, a Bristol Myers Squibb (BMS) company. Zai Lab has an exclusive license to develop and commercialise the therapy in Greater China.

The latest approval was granted based on data from the pivotal open-label, single-arm TRIDENT-1 study, which evaluated Augtyro in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC. Data from this study was previously used to bag Augtyro a US Food and Drug Administration (FDA) approval for the treatment of adults with NSCLC in November 2023.

“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 tumour progression,” said president and Head of Global Oncology Research and Development at Zai Lab Dr. Rafael Amado in the 13 May press announcement.

BMS has been inching closer to acquiring an expanded label for Augtyro after announcing in February that the FDA accepted its supplemental new drug application (sNDA) to include other cancers that have NTRK fusions. The pharma giant supported the sNDA with data from the Phase I/II CARE trial (NCT04094610)—a study in which the therapy was evaluated across neurotrophic receptor tyrosine kinase (NTRK)-positive solid tumours—as well as data from the Phase I/II TRIDENT 1 trial (NCT03093116).  

As per an August 2023 data update for TRIDENT-1, TKI naïve patients demonstrated a confirmed objective response rate (cORR) of 79% while patients with prior TKI treatment saw a cORR of 38%. The therapy has a well characterised safety profile and is manageable with standard treatments.

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According to GlobalData’s consensus forecasts, Augtyro is projected to yield $803m in total sales in 2030. GlobalData is the parent company of Pharmaceutical Technology.