16Nov 2023
FDA Grants Approval to Bristol Myers Squibb's Augtyro™ for ROS1-Positive NSCLC Treatment

FDA Grants Approval to Bristol Myers Squibb's Augtyro™ for ROS1-Positive NSCLC Treatment

Bristol Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) for Augtyro™ (repotrectinib) in treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Administered orally, Augtyro, a tyrosine kinase inhibitor, demonstrated success in the pivotal TRIDENT-1 trial, achieving a 79% objective response rate in TKI-naïve patients. The approval expands Bristol Myers Squibb's NSCLC portfolio, reinforcing its commitment to precision medicine. Augtyro is anticipated to be available to U.S. patients in mid-December 2023, offering a new treatment option for ROS1-positive NSCLC.

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