-- Expands GAVRETO label following initial approval for RET fusion-positive non-small cell lung cancer in September 2020 --
SUZHOU, China, December 10th, 2020 – The partner of CStone Pharmaceuticals (“CStone”, HKEX: 2616), Blueprint Medicines, announced on December 1st that the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of patients with RET-altered thyroid cancers. The accelerated approval expands the labeled indications for GAVRETO to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require 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). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Earlier this year, the FDA granted accelerated approval to GAVRETO for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test. The therapy is jointly commercialized in the U.S. by Blueprint Medicines and Genentech, a wholly owned member of the Roche Group, under Blueprint Medicines’ collaboration with Roche.
Developed by CStone’s partner Blueprint Medicines, pralsetinib is a once-daily oral treatment designed to potently and selectively target RET alterations that drive multiple tumor types.
“We are pleased that pralsetinib has been approved by the U.S. FDA for the treatment of patients with RET-altered thyroid cancers,” said Dr. Frank Jiang, Chairman and CEO of CStone, “ In China, the National Medical Products Administration has accepted pralsetinib’s new drug application with priority review designation for the treatment of patients with RET fusion-positive non-small cell lung cancer. We hope to deliver pralsetinib to a wide range of patients with RET-altered cancers in China.”
CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of pralsetinib in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.
For more details, please go to http://blueprintmedicines.com/GAVRETOthyroid.
CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 16 drug candidates, including 5 late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone’s vision is to become a world-renowned biopharmaceutical company that is leading the way to conquering cancer.
For more information about CStone, please visit: www.cstonepharma.com
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