FDA approved repotrectinib for ROS1-positive lung cancer in November 2023

The Food and Drug Administration granted approval to repotrectinib on November 15, 2023, for use in locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the agency's own announcement. On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).¹

The approval record identifies Bristol-Myers Squibb Company as the sponsor associated with the drug. The document provided does not include further detail on the clinical trial data, dosing information, or regulatory pathway (such as accelerated or standard approval) that supported this decision. It also does not specify additional indications, prior treatment requirements, or any related milestones that may follow this approval.

Readers seeking more detailed clinical trial results, such as response rates or survival data, or information about the regulatory basis for approval, would need to consult additional FDA materials or company filings, as this particular record contains only the approval announcement itself.