Hengrui Pharma Receives FDA Complete Response Letter for Camrelizumab–Rivoceranib Combination in Advanced Liver Cancer
Hengrui Pharma and Elevar Therapeutics have encountered another setback in their efforts to secure U.S. approval for the combination of camrelizumab and rivoceranib, as the FDA has issued a third Complete Response Letter (CRL) for the regimen in first-line liver cancer. Unlike the previous two rejections, which were linked to manufacturing concerns at Hengrui's camrelizumab facility, the latest decision stems from deficiencies identified during an FDA inspection of the rivoceranib (apatinib) manufacturing site. Hengrui noted that the same facility ...
