Levo Therapeutics, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on March 20, 2025, to Elevar Therapeutics, Inc. concerning its New Drug Application (NDA 216586) for rivoceranib tablets. The FDA determined that the application is not approvable in its current state.

The main issue identified is that the safety and effectiveness of rivoceranib have only been established in combination with SHR-1210. Therefore, approval for rivoceranib is contingent upon the regulatory approval of SHR-1210. Additionally, the FDA reserved comments on the proposed Prescribing Information, as well as the Carton and Container Labeling, until the application's core deficiencies are resolved. The proprietary name was conditionally acceptable but requires resubmission after these deficiencies are addressed.

Under the regulatory framework outlined in 21 CFR 314.110, Elevar Therapeutics is required to resubmit the application or take other actions within one year from the CRL date. A resubmission must fully address all identified deficiencies, be clearly marked "RESUBMISSION," and declare itself a complete response. The company may also request a meeting to discuss the path forward. The product cannot be legally marketed until written approval is obtained.