Bristol Myers Squibb (NYSE: BMY) has shared that the U.S. Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) for Augtyro™ (repotrectinib) aimed at treating solid tumors in adults and pediatric patients aged 12 and above. These tumors must have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and be either locally advanced or metastatic, or where surgical removal might lead to severe complications. The filing's acceptance comes after data from the Phase 1/2 TRIDENT-1 trial for adult patients and the CARE study for pediatric patients, both of which showed promising results.

Bristol Myers Squibb, emphasized the persistent unmet needs in treating locally advanced or metastatic solid tumors positive for NTRK. He underscored the importance of new treatment options to enhance response durability and tackle resistance to current therapies.

The application's basis was the positive outcomes from the TRIDENT-1 and CARE trials, with Augtyro demonstrating significant response rates and durable responses, including among patients with common resistance mutations. Additionally, the safety profile of Augtyro was favorable and manageable. The ongoing TRIDENT-1 trial continues to evaluate long-term outcomes and other endpoints, supported by data from the CARE study.

Bristol Myers Squibb expressed gratitude to the patients and investigators participating in the TRIDENT-1 and CARE trials.

Augtyro, acquired through Bristol Myers Squibb's subsidiary Turning Point Therapeutics, represents a potential advancement in treating solid tumors harboring NTRK gene fusions.

The TRIDENT-1 trial is a global, multicenter study evaluating Augtyro's safety and efficacy in patients with various advanced solid tumors, including non-small cell lung cancer (NSCLC) harboring ROS1 or NTRK fusions.

Meanwhile, the CARE trial is focused on assessing Augtyro's safety and activity in pediatric and young adult patients with solid tumors harboring ALK, ROS1, or NTRK1-3 gene alterations.

NTRK gene fusions, while rare, play a significant role in certain cancers, making targeted therapies crucial in treatment strategies.

Bristol Myers Squibb's commitment to transforming cancer care is evident through its focus on personalized medicine, innovative research, and comprehensive patient support initiatives.

Augtyro, with its Breakthrough Therapy Designations and Fast Track designations from the FDA, signifies a potential milestone in addressing unmet medical needs in various solid tumors, particularly NSCLC and pediatric cancers harboring specific gene alterations.

 

Source: businesswire.com

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