FDA accepts for review NDA for pralsetinib to treat patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. -Blueprint Medicines + Genentech/Roche

Blueprint Medicines announced the FDA has accepted the company's new drug application (NDA) for pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. This NDA was accepted for review under the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The FDA granted priority review and set an action date of February 28, 2021 under the Prescription Drug User Fee Act.