FDA Grants Breakthrough Designation to Turning Point’s Nonsmall-Cell Lung Cancer Drug

The FDA has granted Turning Point Therapeutics a Breakthrough Therapy designation for its kinase inhibitor, repotrectinib, for treating nonsmall-cell lung cancer (NSCLC).

The agency awarded the breakthrough designation for the treatment of patients with ROS1-positive metastatic NSCLC who have not been previously treated with a ROS1 tyrosine-kinase inhibitor, also known as tyrosine-kinase inhibitor-naïve patients.

“Repotrectinib … has shown antitumor activity and durable responses among kinase-inhibitor treatment-naïve and pre-treated patients,” the San Diego-based firm said.

Turning Point said that the agency granted the designation based on initial data from patients enrolled in the phase 1 and 2 portions of its TRIDENT-1 study. The company intends to present updated phase 2 trial data on New Year’s Eve.