China-based Chia Tai Tianqing Pharmaceutical announced that its anlotinib (trade name: FOCUS V) has received approval from China’s National Medical Products Administration (NMPA) for use in combination with chemotherapy. The drug is indicated for first-line treatment of unresectable locally advanced or metastatic soft tissue sarcoma (STS) in patients not previously treated with systemic therapy.
Clinical Trial Results
The Phase III study demonstrated that anlotinib in combination with chemotherapy significantly extended median progression-free survival (mPFS) by 5.6 months compared to the control group. The objective response rate (ORR) was six times higher (17.8% vs. 2.9%), and the disease control rate (DCR) showed a substantial increase (79.3% vs. 54.7%).
Regulatory Milestone
This approval marks the ninth indication for anlotinib in China, following previous approvals for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), medullary thyroid carcinoma, differentiated thyroid cancer, endometrial cancer, and other major cancer types.-Fineline Info & Tech
