Bristol Myers Squibb has disclosed that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro™ (repotrectinib) to treat adult and pediatric patients aged 12 and above with solid tumors containing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, which are either locally advanced or metastatic, or where surgical resection poses a risk of severe morbidity. The FDA has granted Priority Review status to the application and set a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024.
Joseph Fiore, Bristol Myers Squibb’s vice president and global program lead for Augtyro, expressed the significance of addressing the unmet needs of patients with NTRK-positive solid tumors. He highlighted the importance of new and effective treatment options in improving response durability and overcoming resistance to existing therapies.
The filing was supported by data from the registrational Phase 1/2 TRIDENT-1 trial for adult patients and the CARE study for pediatric patients with NTRK-positive solid tumors. Augtyro demonstrated clinically meaningful response rates and robust durability of response, even in patients with tumors harboring common resistance mutations. Notably, intracranial responses were observed, and the safety profile of Augtyro was deemed well-tolerated and manageable.
Furthermore, the FDA approval of Augtyro for the treatment of adult patients with ROS1-positive non-small cell lung cancer (NSCLC) in November 2023 U.S. Food and Drug Administration.
Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the TRIDENT-1 and CARE trials, recognizing their invaluable contributions to advancing medical research and patient care.
It’s important to note that Turning Point Therapeutics, a subsidiary of Bristol Myers Squibb, owns repotrectinib, following Bristol Myers Squibb’s acquisition of the company in August 2022.
