Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
The 2020 World Conference on Lung Cancer, which was scheduled to take place in Singapore last August, is set to kick off virtually later this week. The postponement gave companies time to generate additional data as they battle to treat patients with their targeted therapies.
Personalized medicine, also referred to as precision or targeted medicine, continues to have a significant impact on the treatment of diseases, particularly cancer. Over the past decade or so there has been a dramatic surge in research and development investments in this field. According to the Washington-based Personalized Medicine Coalition, there are about 286 such medicines on the market currently, a number that has more than doubled from the 132 that were available in 2016, representing the largest four-year increase since the PMC began tracking personalized therapies back in 2008.
The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.