Roche Holding AG's biotech arm Genentech Inc. picked up a U.S. regulatory win for Rozlytrek, its drug for lung cancer.
Rozlytrek is the third medicine to receive U.S. Food and Drug Administration approval for this indication. The others are Merck & Co. Inc.'s Keytruda and Bayer AG's Vitrakvi, the FDA said.
The treatment is for patients who have non-small cell lung cancer that has spread to other parts of the body and who express ROS1, a certain genetic abnormality. ROS1 is a biomarker for that type of cancer.
Further, Rozlytrek received accelerated approval as a treatment for patients with solid tumors that have certain gene rearragements called NTRK gene fusion, that do not have a known acquired resistance mutation.
The approvals are based on results from a series of studies in which the drug was tested for several types of cancer. For ROS1-positive, non-small cell lung cancer, the drug shrank tumors in 78% of patients.
"We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue-agnostic therapies, which have the potential to transform cancer treatment," FDA acting Commissioner Ned Sharpless said in an Aug. 15 statement. "We're seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine."