Deciphera Pharmaceuticals, Inc.

FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor Treatment, Showing 40% Response Rate

3 months ago

• The FDA has granted approval to vimseltinib (DCC-3014) for treating symptomatic tenosynovial giant cell tumor (TGCT), based on positive Phase 3 MOTION trial results. • The pivotal MOTION study demonstrated a significant 40% objective response rate for vimseltinib compared to 0% for placebo, with notable improvements in patient mobility and pain. • The twice-weekly oral medication showed a manageable safety profile, with mostly grade 1-2 adverse events, providing a new therapeutic option for TGCT patients.

Zai Lab's Augtyro Included in China's National Reimbursement Drug List for ROS1+ NSCLC

6 months ago

• Zai Lab's Augtyro (repotrectinib) has been added to China's National Reimbursement Drug List (NRDL) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). • The NRDL update also includes the renewal of Nuzyra (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). • Qinlock (ripretinib) is also renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors. • The inclusion of these drugs in the NRDL aims to improve patient access to innovative treatments at more affordable costs throughout China.

FDA Grants Priority Review to Vimseltinib for Tenosynovial Giant Cell Tumor

9 months ago

• The FDA has granted priority review to vimseltinib for treating tenosynovial giant cell tumor (TGCT), setting a PDUFA goal date of February 17, 2025. • Vimseltinib, a CSF1R inhibitor, demonstrated a 40% overall response rate in the MOTION phase 3 trial, significantly higher than placebo (0%). • The MOTION trial also showed statistically significant improvements in active range of motion, physical function, and pain reduction with vimseltinib. • Vimseltinib's manageable safety profile, without cholestatic hepatotoxicity or drug-induced liver injury, positions it as a potential new treatment option.