Research & Development
US FDA approves Blueprint Medicines' GAVRETO for treatment of patients with RET-altered thyroid cancers
2 December 2020 -

The United States Food and Drug Administration (FDA) has approved United States-based Blueprint Medicines Corporation's (NASDAQ: BPMC) GAVRETO (pralsetinib) intended for the treatment of patients with RET-altered thyroid cancers, it was reported on Tuesday.

The accelerated approval increases the labelled indications for the product to include adult and paediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who need systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

The product is a once-daily oral precision therapy aimed to potently and selectively target RET alterations that drive multiple tumour types. It is jointly commercialised in the United States by Blueprint Medicines and Genentech, a wholly owned member of the Roche Group, under Blueprint Medicines' collaboration with Roche.

The approval is based on efficacy and safety results from the ARROW trial.

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