Elevar Therapeutics, the company developing a rivoceranib and camrelizumab combination therapy for first-line treatment of liver cancer, addressed the latest regulatory trends, emphasizing the FDA's evolving regulations in response to scientific advancements. Seong H. Jang, Chief Operating Officer of Elevar Therapeutics, presented these insights at the Korea International Conference on Clinical Trials 2024 (KIC 2024) in Seoul.
Jang, who previously spent 20 years at the FDA, discussed the accelerated approval pathway and "Project Optimus," the oncology drug dose optimization initiative. He noted that the FDA forms working groups to draft guidelines, which are then reviewed by external experts, a process that can take six months to a year.
FDA's Accelerated Approval Pathway
Jang explained that the accelerated approval pathway aims to provide patients with serious conditions faster access to treatment. This pathway grants conditional approvals based on surrogate endpoints, requiring confirmatory clinical trials for final approval.
Project Optimus: Optimizing Anticancer Drug Dosing
Project Optimus represents the FDA's new approach to determining the correct dose for anticancer drugs. Jang emphasized the importance of establishing an optimal dose level rather than using high doses, stating that excessive dosing can reduce the effectiveness of anticancer drugs, including bispecific antibodies.
Rivoceranib and Camrelizumab Combination Therapy Review
Regarding the new drug application review for the rivoceranib and camrelizumab combination, Jang clarified that it is a Class 2 (C2) review. This classification means the FDA requested a re-inspection of the production site, but does not require additional clinical studies or data submissions. Jang refuted inaccurate media reports suggesting the need for further clinical trials, confirming that "no additional clinical trials are required."
