8

September

Approval of GAVRETO™ (pralsetinib)

CAMBRIDGE, Mass., September 4, 2020 – 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. See the full Press Release HERE

To view GAVRETO’s product website, please visit www.GAVRETOHCP.com

To review the full Prescribing Information for GAVRETO, please click https://www.blueprintmedicines.com/uspi/GAVRETO.pdf

Victoria

Victoria has blogged 1100 posts