FDA Approves Pralsetinib for Metastatic RET+ NSCLC


The FDA has approved pralsetinib for the treatment of patients with metastatic, RET fusion–positive non-small cell lung cancer.

The FDA has approved pralsetinib (Gavreto) for the treatment of adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.

“The FDA approval of [pralsetinib] for RET fusion–positive NSCLC is an important step toward our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, stated in a press release. “We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of [pralsetinib] across multiple RET-altered tumor types.”

The regulatory decision was based on the data from the phase 1/2 ARROW trial, in which treatment with pralsetinib elicited durable clinical responses in patients with RET fusion–positive disease who had or had not received previous treatment, irrespective of RET fusion partner or central nervous system involvement.

Results demonstrated an overall response rate (ORR) of 57% (95% CI, 46%-68%) and a complete response (CR) rate of 5.7% in a total of 87 patients with NSCLC who received prior treatment with platinum-based chemotherapy. Moreover, the median duration of response (DOR) has not yet been reached (95% CI, 15.2 months­–not reached). Among 27 treatment-naïve patients, the ORR was even higher, at 70% (95% CI, 50%-86%) with a CR rate of 11%.

With regard to safety, the most commonly reported adverse effects with the agent included fatigue, constipation, musculoskeletal pain, and increased blood pressure, according to Genentech.

The FDA has also granted pralsetinib a priority review for use in patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancer, and the regulatory agency are expected to make a decision by February 28, 2021.


Genentech announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer. News release. Genentech. September 4, 2020. Accessed September 4, 2020. https://bwnews.pr/2QWJ4LM.

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