Ngwa ọgwụ ọhụrụ maka ọgwụgwọ ọrịa kansa thyroid

CStone Pharmaceuticals today announced that the National Medical Products Administration (NMPA) of China has approved the supplemental new drug application (sNDA) of selective RET inhibitor GAVRETO® (pralsetinib) for the treatment of RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer (TC). The approval expanded the labeled indications of GAVRETO in China to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who requires systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive TC who requires systemic therapy and radioactive iodine-refractory (if radioactive iodine treatment is appropriate).

Discovered by CStone’s partner Blueprint Medicines, GAVRETO is a potent and selective RET inhibitor. CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

Dr. Frank Jiang, Chairman and CEO of CStone, said, “We are very glad about the sNDA approval of GAVRETO, which will provide a new treatment option for Chinese patients with advanced RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. We also want to extend our special thanks to the NMPA for the priority review. CStone is always committed to developing innovative therapies to address the unmet medical needs of cancer patients. We will continue to enhance the clinical value and potential of our pipeline, and step up efforts to provide patients worldwide with high-quality, innovative drugs.”

Professor Ming Gao, a Principal Investigator of the ARROW study and President of Tianjin Union Medical Center, said, “The incidence rate of thyroid cancer has been rising in recent years. There are limited treatment options clinically for the treatment of MTC, and there is an urgent need for precision therapies, especially for patients with RET-mutant MTC. GAVRETO demonstrated robust and durable anti-tumor activity in Chinese patients with advanced or metastatic RET-mutant MTC, with overall safety consistent with the results seen in the global ARROW study. With this expansion of GAVRETO’s labeled indications, we look forward to addressing unmet clinical needs of thyroid cancer patients.”

Dr. Jason Yang, Chief Medical Officer of CStone, said, “The NMPA approval of the sNDA is another key milestone for us after GAVRETO was approved for the treatment of patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer. We’d like to thank all patients and investigators who contributed to the clinical study of GAVRETO in the expanded indications. We will continue to advance clinical research of GAVRETO for the treatment of multiple types of cancers so that we can quickly bring forward this innovative therapy to help benefit more patients.”

The sNDA approval is based on results from the global phase 1/2 ARROW trial, designed to evaluate the safety, tolerability and efficacy of GAVRETO in patients with RET fusion-positive NSCLC, RET-mutant MTC, and other advanced solid tumors with RET fusions. As of a data cutoff date of April 12, 2021, a total of 28 patients with advanced RET-mutant MTC were enrolled in the China MTC registrational bridging cohort of the global ARROW study, and received a starting GAVRETO dose of 400mg once daily. The study results showed that the confirmed objective response rate (ORR) of 26 RET-mutant MTC patients with measurable disease at baseline was 73.1%, including 3 with complete response (CR) and 16 with partial responses (PR). The disease control rate (DCR) was 84.6%, and responses were observed regardless of RET mutation genotype. Among the 19 patients with confirmed response, the median duration of response (DOR) was not reached, and the 9-month DOR rate was 100%. Calcitonin and carcinoembryonic antigen (CEA) levels were substantially reduced. GAVRETO was generally well-tolerated, with no new safety signals detected. The results for the China registrational bridging cohort were presented during a late breaking oral abstract session at the 90th Annual Meeting of the American Thyroid Association (ATA) 2021.