CStone Pharmaceuticals (HKG: 2616) has announced receiving marketing approval in Taiwan for its RET inhibitor Gavreto (pralsetinib), a drug in-licensed from US-based biotech Blueprint Medicines in June 2018. The approval covers the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic RET mutant medullary thyroid cancer (MTC) requiring systemic treatment, and advanced or metastatic RET fusion-positive thyroid cancer requiring systemic treatment and ineffective after radioiodine treatment (if applicable).
Clinical Data and Safety Profile
The approval is based on the results of the global Phase I/II ARROW study, which assessed the safety, tolerability, and efficacy of Gavreto in RET fusion-positive NSCLC, RET variant thyroid cancer, and other RET fusion advanced solid tumors. The study demonstrated that Gavreto delivered lasting clinical benefits, with strong and durable anti-tumor activity in patients with advanced RET fusion-positive NSCLC, RET mutation MTC, and RET fusion thyroid cancer. The most common treatment-related adverse events (TRAEs) were elevated transaminase and neutropenia, which were overall safe and controllable, with no new safety signals identified.
Market Approvals and Future Outlook
Gavreto, an oral, once-daily, highly selective RET inhibitor, has been approved in China to treat 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 who need systematic treatment, and adults with advanced or metastatic RET fusion-positive thyroid cancer and children aged 12 and above who need systematic treatment and are refractory to radioactive iodine (if applicable). The drug was previously approved in Hong Kong in July last year for treating RET fusion-positive NSCLC. With this latest approval in Taiwan, CStone continues to expand Gavreto’s reach in addressing significant unmet needs in RET-driven cancers.-Fineline Info & Tech
