Bristol Myers Squibb Co.
BMY,
said Tuesday the U.S. Food and Drug Administration has accepted for priority review its application for repotrectinib as a treatment for patients with certain kinds of non-small cell lung cancer. Repotrectinib was the lead experimental drug of Turning Point Therapeutics, which Bristol Myers acquired for $3.8 billion in June of 2022. The treatment targets patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and has shown positive results in that patient group in an ongoing trial called Trident-1. If approved, the drug would provide a potential best-in-class treatment for those patients, said Bristol Myers. The FDA has set a target action date of Nov. 27. The priority review process shortens the length of time the regulator takes to approve a therapy and is used for serious illnesses with no approved treatments. Lung cancer is the leading cause of cancer deaths globally and non-small lung cancer is one of the most common types. Bristol Myers’ stock was up 0.7% premarket but has fallen 11.3% in the year to date, while the S&P 500
SPX,
has gained 9.5%.
