Rigel Pharmaceuticals Completes Transfer of GAVRETO® (pralsetinib) New Drug Application
GAVRETO will be available from Rigel in the U.S. beginning June 27, 2024
SOUTH SAN FRANCISCO, Calif., June 24, 2024 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (“Rigel”) (Nasdaq: RIGL) today announced the completion of the transfer to Rigel of the New Drug Application (NDA) for 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 a U.S. Food and Drug Administration (FDA) approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). GAVRETO will be commercially available from Rigel in the U.S. by prescription beginning June 27, 2024.