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Pharma makers expect the treatment to be available within a week.
FDA cleared another targeted therapy to treat non-small cell lung cancer (NSCLC), reflecting the growth in precision medicines.
Pralsetinib (Gavreto, Blueprint Medicines) is designed to treat adults with metastatic rearranged during transfection (RET) fusion-positive NSCLC as detected by an FDA-approved test.
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The once-daily therapy is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately 1% to 2% of patients with NSCLC. RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.
Blueprint Medicines and Genentech, a member of the Roche Group, will co-commercialize Gavreto in the U.S. and expect to have it available in the next week.
"Targeted therapies have dramatically improved care for patients with non-small cell lung cancer driven by oncogenes…and the approval of the selective RET inhibitor pralsetinib, or Gavreto, marks another milestone in a paradigm shift toward precision medicine," said Vivek Subbiah, MD, associate professor of Investigational Cancer Therapeutics and center medical director of the Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center, and an investigator on the ARROW trial. in a Blueprint press release.
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“This approval represents an important advance with the potential to change standards of care for patients with RET fusion-positive non-small cell lung cancer, who have historically had limited treatment options,” Subbiah added.
The Phase 1/2 ARROW clinical trial showed efficacy for Gavreto in patients with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement, Blueprint said.
"Patients treated with GAVRETO had durable clinical responses, with a subset achieving complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer. We observed this activity with or without prior therapy and regardless of RET fusion partner or the presence of brain metastases,” Subbiah said.