Dr. Subbiah on the FDA Approval of Pralsetinib in RET+ NSCLC

Vivek Subbiah, MD, associate professor in the Investigational Cancer Therapeutics Department and center clinical medical director of the Clinical Center for Targeted Therapy, of the Cancer Medicine Division, at The University of Texas MD Anderson Cancer Center, discusses the clinical implications of the approval of pralsetinib (Gavreto; formerly BLU-667) in patients with RET fusion–positive non–small cell lung cancer (NSCLC).

The September 4, 2020 FDA approval is based on data from the ongoing phase 1/2 ARROW trial (NCT03037385), in which pralsetinib induced an overall response rate (ORR) of 57% and a complete (CR) of 5.7% in 87 patients with NSCLC who were previously treated with platinum-based chemotherapy. The median duration of response had not yet been reached.

Among 27 patients with treatment-naïve patients with NSCLC, ORR was 70% with a CR rate of 11%.

According to Subbiah, the data confirm the utility of RET as a molecular driver and therapeutic target similar to EGFR, ALK, and ROS1.

Moreover, the approval underscores the need for patients to undergo next-generation sequencing to identify whether they are eligible to receive targeted therapy, Subbiah says.

Finally, the approval suggests pralsetinib could be developed for use in a broader patient population in the future, concludes Subbiah.