FDA sends CRL for Combination of Rivoceranib and Camrelizumab as 1L Treatment for Unresectable or Metastatic HCC
“The Company is reviewing the contents of the letter and intends to work closely with the FDA to determine the appropriate path forward. While we are disappointed by this outcome, we remain committed to patients with hepatocellular carcinoma and to advancing the development of rivoceranib and camrelizumab,” said Dong-Gun Kim, Chief Executive Officer of Elevar Therapeutics. “We will engage with the FDA promptly to fully understand the agency’s feedback and determine the most effective path forward. Importantly, we continue to believe in the strength of the clinical data supporting this combination and remain committed to pursuing opportunities that may bring this treatment option to patients in need.”
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