Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Adults with Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer – Blueprint Medicines

Sourced from Blueprint Medicines News Release

— GAVRETO, the only once-daily RET-targeted therapy, demonstrated durable efficacy, with complete responses in a subset of patients —

— Blueprint Medicines and Genentech will co-commercialize GAVRETO in the U.S. —

— FDA approval underscores Blueprint Medicines’ commitment to deliver a portfolio of transformative precision therapies to patients with NSCLC —

— NDA accepted by FDA for pralsetinib for RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer —

— Blueprint Medicines to host conference call on Tuesday, September 8, 2020 at 8:00 a.m. ET —

CAMBRIDGE, Mass., Sept. 4, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. The approval is based on data from the Phase 1/2 ARROW clinical trial, which 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. Under Blueprint Medicines’ collaboration with Roche, Blueprint Medicines and Genentech, a member of the Roche Group, will co-commercialize GAVRETO in the U.S.

GAVRETO is a once-daily oral RET-targeted therapy developed by Blueprint Medicines. It is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately 1 to 2 percent of patients with NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.

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By Jessica Yap-Chung
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