BMS and Zai Lab's Augtyro Approved by NMPA for NSCLC

Zai Lab has recently announced that its New Drug Application (NDA) for Augtyro (repotrectinib) has been approved by China’s National Medical Products Administration (NMPA). Augtyro is intended for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This drug, which is administered orally, functions as a tyrosine kinase inhibitor (TKI), aiming to inhibit specific kinases, thereby halting disease progression and tumor growth.

The drug is currently under evaluation in the Phase I/II TRIDENT-1 study (NCT03093116) by Turning Point Therapeutics, a subsidiary of Bristol Myers Squibb (BMS). Zai Lab holds exclusive rights to develop and commercialize Augtyro in Greater China. This recent approval from the NMPA is based on substantial data from the TRIDENT-1 study, a pivotal open-label, single-arm trial that assessed Augtyro in both TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC. This study also facilitated Augtyro's approval by the US Food and Drug Administration (FDA) for treating adults with NSCLC in November 2023.

Dr. Rafael Amado, President and Head of Global Oncology Research and Development at Zai Lab, emphasized the importance of this approval in a press release on May 13. He pointed out the significant unmet need among patients due to the limited efficacy of existing treatments, which often lead to resistance and subsequent tumor progression.

Bristol Myers Squibb is also working to expand Augtyro's label to cover other cancers that have NTRK fusions. In February, the FDA accepted its supplemental new drug application (sNDA) for this expanded use. This application was bolstered by data from the Phase I/II CARE trial (NCT04094610), which evaluated the drug across neurotrophic receptor tyrosine kinase (NTRK)-positive solid tumors, as well as additional data from the TRIDENT-1 trial.

According to an August 2023 data update for TRIDENT-1, TKI-naïve patients demonstrated a confirmed objective response rate (cORR) of 79%, while those who had undergone prior TKI treatments showed a cORR of 38%. The safety profile of Augtyro is well-documented and can be managed with standard treatments.

Projections by GlobalData forecast that Augtyro will generate $803 million in total sales by 2030. This underscores the drug's potential impact on the market, particularly given its efficacy and manageable safety profile.

In conclusion, the approval of Augtyro by China's NMPA marks a significant milestone in the treatment of ROS1-positive NSCLC. With ongoing studies and potential label expansions, the drug offers hope for improved outcomes for patients facing this challenging cancer.