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FDA Approves Gavreto for Treatment of RET-Positive, Metastatic NSCLC

Dec 14, 2023
The FDA granted accelerated approval to pralsetinib (Gavreto, Blueprint Medicines) for adults with metastatic RET fusion–positive non-small cell lung cancer (NSCLC) detected by an FDA-approved test. Read more…

FDA Approves Gavreto for Treatment of RET-Positive, Metastatic NSCLC 

The FDA granted accelerated approval to pralsetinib (Gavreto, Blueprint Medicines) for adults with metastatic RET fusion–positive non-small cell lung cancer (NSCLC) detected by an FDA-approved test.

“Targeted therapies have dramatically improved care for patients with non-small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib … marks another milestone in a paradigm shift toward precision medicine,” said Vivek Subbiah, MD, an associate professor of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, in Houston, and an investigator on the ARROW trial, which led to the approval. 

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