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NDA Resubmission Planned for Rivoceranib/Camrelizumab in ... - OncLive

Elevar Therapeutics will resubmit an NDA for rivoceranib plus camrelizumab for unresectable HCC treatment after FDA's CRL cited manufacturing issues, not clinical data. The CARES-310 trial showed significant OS and PFS improvements over sorafenib, with a median OS of 23.8 months for the combination therapy.


Reference News

NDA Resubmission Planned for Rivoceranib/Camrelizumab in ... - OncLive

Elevar Therapeutics will resubmit an NDA for rivoceranib plus camrelizumab for unresectable HCC treatment after FDA's CRL cited manufacturing issues, not clinical data. The CARES-310 trial showed significant OS and PFS improvements over sorafenib, with a median OS of 23.8 months for the combination therapy.

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