Elevar Therapeutics, Inc.: rivoceranib

Please refer to your May 16, 2023, new drug application (NDA), and your amendments, submitted under oe for rivoceranib tablet.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.

(1) Because the safety and effectiveness of |') (rivoceranib) has only been established in combination with SHR-1210, we will not approve rivoceranib until a regulatory approval action is issued for SHR-1210.

(1) Because the safety and effectiveness of om (rivoceranib) has only been established in combination with SHR-1210, we will not approve rivoceranib until a regulatory approval action is issued for SHR-1210.