▎WuXiEdited by Kant Content Team

Bristol-Myers Squibb today announced that the U.S. FDA has accepted the supplemental New Drug Application (sNDA) for its drug Augtyro (repotrectinib) to treat adult and pediatric patients aged 12 years and older with locally advanced or metastatic solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions.NTRK) Gene fusion positive.The U.S. FDA granted this application Priority Review designation and set the PDUFA date for June 15, 2024.

The application is primarily based on the results of the TRIDENT-1 and CARE trials. In the TRIDENT-1 study, Augtyro...NTRKShowed a clinically meaningful response rate in patients with locally advanced or metastatic solid tumors who are positive. Including patients whose tumors have common resistance mutations,Augtyro treatment demonstrates a high degree of sustained relief, with observed intracranial responses in patients.Augtyro has good safety, is well-tolerated, and its safety is generally controllable. The TRIDENT-1 study is still ongoing to evaluate the long-term treatment outcomes of the drug and other trial endpoints.

The data from the CARE study also support the results of the TRIDENT-1 trial, which evaluated the role of Augtyro in treating pediatric and young adult patients with locally advanced or metastatic solid tumors who carryALK、ROS1OrNTRK1-3Gene mutation.

Augtyro, initially developed by Turning Point Therapeutics, is a ROS1 and NTRK targeted inhibitor.It has a unique structure, with the binding site to the target protein located within the "ATP pocket," and it is unaffected by various drug-resistant mutations. Therefore, it can overcome multiple genetic mutations that confer resistance to other TKIs, killing cancer cells carryingROS1OrNTRKMultiple tumor cells with gene fusion. Augtyro in November last yearFDA ApprovedUsed forTreatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)

In July 2020, Zai Lab announced a collaboration with Turning Point to obtain exclusive development and commercialization rights for Augtyro in Greater China. According to the terms of the agreement, Turning Point received an upfront payment of $25 million and potential milestone payments of up to $151 million. In June 2022, Bristol-Myers Squibb Company announced an agreement with Turning Point to acquire the latter for over $4 billion, thereby incorporating Augtyro into its R&D pipeline.

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