Rigel Pharmaceuticals Completes Transfer of GAVRETO® (pralsetinib) New Drug Application

Core Viewpoint - Rigel Pharmaceuticals has completed the transfer of U.S. commercial rights for GAVRETO (pralsetinib) and will make it available for prescription starting June 27, 2024, targeting patients with specific types of cancer [1][2][4]. Group 1: Product Information - GAVRETO is indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for adult and pediatric patients aged 12 and older with advanced or metastatic RET fusion-positive thyroid cancer [5][6]. - The recommended dosage for GAVRETO is 400 mg taken orally once daily [3]. - GAVRETO is the only once-daily oral RET-inhibitor therapy designed to selectively target RET in mNSCLC and advanced or metastatic thyroid carcinoma [3]. Group 2: Pricing and Support - GAVRETO will be supplied in two configurations: 100 mg bottles of 60 capsules priced at $11,144.58 and 100 mg bottles of 90 capsules priced at $16,716.85 [3]. - Rigel offers patient assistance programs through RIGEL ONECARE, which provides support for insurance coverage and financial assistance for eligible patients [3]. Group 3: Market Context - Rigel acquired the U.S. commercial rights to GAVRETO from Blueprint Medicines Corporation in February 2024, marking a strategic expansion in its hematology and oncology business [4][2]. - The NSCLC market is significant, with over 230,000 adults expected to be diagnosed with lung cancer in the U.S. in 2024, where NSCLC accounts for 80-85% of all lung cancer cases [5].