FDA rejects Hengrui-Elevar liver cancer drug combo for third time over manufacturing issues

FDA has again turned down a liver cancer drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics.

This is the third rejection in roughly two years, with the agency citing persistent manufacturing deficiencies as the primary reason.

The combo was intended to treat the most common form of liver cancer, and the repeated setbacks delay any potential market entry and raise concerns about the companies' production processes.

The ongoing regulatory hurdles may affect investor confidence and could prompt the firms to address quality issues before resubmitting.