AUGTYRO™

November 15, 2023

FDA Approves Augtyro™ for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

Bristol Myers Squibb has announced that the U.S. Food and Drug Administration approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Administered as an oral therapy, Augtyro capsules are administered once daily for 14 days, then twice daily, with or without food. It is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.

Lung cancer is the leading cause of cancer deaths in the United States. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) represents up to 85% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed.

Augtyro is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients. It is expected to be available to patients in the U.S. in mid-December 2023.

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