The FDA approved Bristol Myers Squibb And Co's (NYSE:BMY) Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

The pharma giant added the drug via a $4.1 billion buyout of Turning Point Therapeutics last year.

Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.

The approval is based on the TRIDENT-1 Phase 1/2 trial that evaluated Augtyro in TKI-naïve and TKI-pretreated patients.

In TKI-naïve patients (n=71), the primary endpoint of objective response rate (ORR), defined as the percentage of people treated within a certain time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79%.

The median duration of response (mDOR) was 34.1 months. 

Among patients pretreated with one prior ROS1 TKI and no prior chemotherapy (n=56), the ORR was 38% (95% CI: 25 to 52), and the mDOR was 14.8 months.

Among those who had measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were observed in 7 of 8 TKI-naïve patients (n=71) and 5 of 12 of those who were TKI-pretreated (n=56).

Reuters noted the drug is set to compete in a crowded market for lung cancer treatments that includes Bristol Myers' other cancer treatment, Opdivo, and rival cancer drugs from Roche Holdings AG (OTC:RHHBY), Merck & Co Inc (NYSE:MRK), and AstraZeneca Plc (NASDAQ:AZN).

Augtyro is expected to be available to patients in the U.S. in mid-December 2023. 

Price Action: BMY shares closed at $51.57 on Wednesday.