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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,
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"GAVRETO will be available from Rigel in the U.S. beginning June 27, 2024\nSOUTH 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.\n\"The transfer of U.S. rights to GAVRETO has been completed and we are excited to announce that GAVRETO – a once-daily, oral targeted therapy for patients with RET fusion-positive mNSCLC and advanced thyroid cancer – will be available to patients from Rigel beginning this week. Our distributors, patient services, and field teams are ready and committed to ensuring both existing and new patients and providers can have access to this important treatment option without interruption,\" said Raul Rodriguez, Rigel's president and CEO. \"The addition of GAVRETO to our commercial portfolio is another important step forward in our strategy to leverage our existing infrastructure and expertise to expand our hematology and oncology business.\"\nGAVRETO's NSCLC indication is fully approved by the FDA and its advanced thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for the advanced thyroid indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Discussions with the FDA regarding confirmatory requirements are ongoing.\nGAVRETO is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in mNSCLC and advanced or metastatic thyroid carcinoma. The recommended dosage of GAVRETO is 400 mg taken orally once daily. GAVRETO will be supplied as follows:\nNDC Number\nCapsule Strength\nPackage Configuration\nWAC Price\n71332-006-60\n100 mg\nBottle...