CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval in Hong Kong for treating adults with RET fusion-positive metastatic non-small cell lung cancer (NSCLC). The drug, licensed from US-based Blueprint Medicines in June 2018, was approved based on data from the global Phase I/II ARROW study.
Drug Profile
Gavreto demonstrated durable clinical benefits and manageable side effects in patients receiving 400 mg once daily, as shown in data from November 2020. The ARROW study assessed pralsetinib’s efficacy and safety in RET fusion-positive NSCLC, RET-mutant medullary thyroid carcinoma (MTC), and other advanced solid tumors.
Regulatory Milestones
- March 2021: First China approval for Gavreto in locally advanced or metastatic RET fusion-positive NSCLC.
- 2022: Expanded China approval for RET-mutant MTC and RET fusion-positive thyroid cancer.-Fineline Info & Tech
