Daiichi Sankyo (DSNKY.US) has submitted an application for its new oral cancer drug in China.

On January 15, the latest official announcement on the website of the National Medical Products Administration's Drug Review Center (CDE) revealed that the application for the first approval of the new drug, pexidartinib capsules (PLX3397) submitted by DSNKY (DSNKY.US), has been accepted. The product was officially included in the priority review by CDE in October 2024, which is suitable for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) adult patients with severe lesions or functional impairment and cannot be improved by surgery. According to public information, pexidartinib is a small molecule inhibitor of CSF1R. It was approved by the US FDA in August 2019 for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adult patients. According to the FDA's press release at the time, it was the first treatment approved by the FDA for TGCT. Tenosynovial giant cell tumor (TGCT) is also known as pigmented villonodular synovitis, a rare non-malignant tumor with local invasion. It can affect the synovium covered joints, bursae and tendon sheaths, leading to joint or limb swelling, pain, stiffness, and decreased range of motion. Currently, surgery is the standard treatment for TGCT. However, for recurrent, refractory or diffuse TGCT patients, surgery is not only difficult to remove the tumor but also may cause serious joint damage and functional loss. For some patients, they may consider amputation to relieve their pain. Pexidartinib is an innovative oral CSF1R small molecule inhibitor that also inhibits c-kit and FLT3-ITD activity. The CSF1R signaling pathway is a major factor driving abnormal cell proliferation in the synovium.