FDA PDUFA Date for Resubmitted NDA for Rivoceranib + Camrelizumab combo in 1L Unresectable or Metastatic HCC Announced
“The results from the CARES-310 study support our continued evaluation of the combination of camrelizumab and rivoceranib as a potential first-line therapy to improve outcomes for patients facing limited treatment options in unresectable hepatocellular carcinoma, which we continue to keep top of mind while navigating the regulatory landscape,” said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. “We are pleased to receive classification of this NDA resubmission, jointly with Hengrui’s BLA resubmission for camrelizumab and will work closely with the FDA as it reviews the applications.”
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