China approves new drug for rare joint tumor

Germany-headquartered science and technology giant Merck announced that pimicotinib, a colony-stimulating factor-1 receptor (CSF-1R) inhibitor, has been approved in China on Monday, bringing a new treatment option to adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause functional limitation or relatively severe morbidity.

TGCT is a rare but locally aggressive joint tumor that causes progressive swelling, stiffness and reduced mobility, significantly disrupting daily activities and quality of life for otherwise healthy patients.

Pimicotinib is the first Class 1 chemical drug approved in China for the treatment of TGCT, with its approval based on results from the global Phase 3 MANEUVER study, in which the drug demonstrated significant improvements in clinical outcomes, the company said.

Niu Xiaohui, director of the Bone and Soft Tissue Tumor Diagnosis and Research Center at Beijing Jishuitan Hospital, said the approval of pimicotinib will give doctors in China access to an effective and well-tolerated systemic therapy, representing a long-awaited breakthrough in treating this difficult condition.

"This approval gives patients an opportunity to alter the course of their disease and ease symptoms that affect daily life. We are working to make pimicotinib available to patients in China as soon as possible, while continuing to advance regulatory applications in other markets," said Danny Bar-Zohar, CEO Healthcare and a member of the Executive Board of Merck.