HLB’s Liver Cancer Drug Fails FDA Approval for Third Time After 9 Deficiencies Cited at Manufacturing Facility

HLB’s liver cancer drug combination therapy involving rivoceranib has received its third rejection from the U.S. Food and Drug Administration after nine additional deficiencies were identified at another manufacturing facility. The facility cited this time is responsible for producing finished drug products, and the FDA raised issues including inadequate aseptic processing and quality control. Along with submitting a corrective action plan, HLB plans to consider a two-track strategy of securing a U.S. contract manufacturing organization to support a sales goal of more than 10 years in the future.