China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) of China has granted approval for a supplemental new drug application (sNDA) for Gavreto (pralsetinib). This approval is for the first-line treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC). CStone obtained the rights to Gavreto from US-based biotech Blueprint Medicines (NASDAQ: BPMC) in June 2018.
ARROW Study Supports sNDA Approval
The approval of this sNDA is supported by the findings from the ARROW study, a global phase I/II clinical trial. The study aimed to evaluate the safety, tolerability, and efficacy of Gavreto in patients with RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), and other advanced solid tumors with RET alterations. As of March 4, 2022, 68 patients with advanced RET fusion-positive NSCLC were enrolled across 10 sites in China and initiated treatment with a 400 mg daily dose of Gavreto. Among these, 37 had received prior platinum-based chemotherapy, while 31 had no prior systemic treatment. For treatment-naïve patients with measurable disease at baseline (n=30), the confirmed objective response rate (ORR) was 83.3%, with a disease control rate (DCR) of 86.7%.
Gavreto’s Selective RET Inhibition and Broad Approval
Gavreto, an oral, once-daily, highly selective RET inhibitor, has been approved in China for a variety of RET-related conditions. These include adult patients with locally advanced or metastatic NSCLC with RET gene fusion-positive who have previously received platinum-containing chemotherapy, adults with advanced or metastatic RET mutant MTC, and children aged 12 and above requiring systemic treatment. Additionally, it is approved for adults with advanced or metastatic RET fusion-positive thyroid cancer and children aged 12 and above who are refractory to radioactive iodine treatment. Gavreto is also registered in Hong Kong, Taiwan, the US, and the EU, among other markets.-Fineline Info & Tech
