Elevar Therapeutics, developing the rivoceranib and camrelizumab combination therapy as a first-line treatment for liver cancer, has shared the latest regulatory trends, emphasizing that U.S. FDA regulations are changing as science evolves.
Seong H. Jang, chief operating officer of Elevar Therapeutics, delivered a presentation during the “FDA & EMA Updates” session at the Korea International Conference on Clinical Trials 2024 (KIC 2024) on Tuesday at Seoul Dragon City in Yongsan-gu, Seoul.
COO Jang, who spent 20 years at the U.S. FDA before joining Elevar Therapeutics, presented on “Regulatory Science in FDA: Updates in Accelerated Approval Pathway and Oncology Drug Dose Optimization.”
Noting that science is constantly changing and regulators must update their guidelines to keep up, Jang discussed the FDA’s accelerated approval pathway and the oncology drug dose optimization initiative, “Project Optimus.”
“Within the FDA, working groups are formed to draft guidelines, which external experts then review,” Jang said, explaining the regulatory update process. He noted that this process can take at least six months and up to a year to finalize and that pharmaceutical companies must be prepared to respond to the latest regulatory requirements in a changing regulatory environment.
COO Jang explained that the accelerated approval pathway is designed to provide patients with serious conditions with faster access to treatment. Under this pathway, conditional approvals are granted using surrogate endpoints instead of traditional clinical targets, followed by confirmatory clinical trials for final approval.
In addition, he emphasized that Project Optimus is the FDA’s new approach to finding the correct dose for anticancer drugs, emphasizing the importance of establishing an optimal dose level rather than the traditional principle of using high doses.
“For anticancer drugs, too much dosing can make them less effective,” Jang said, adding that optimal dosing is essential for newer anticancer drugs, including bispecific antibodies.
‘FDA only requests re-diligence, so no additional clinical trials are needed’
Asked whether the new drug application review for the rivoceranib+camelizumab combination, which Elevar Therapeutics recently submitted to the FDA, is a Class 1 (C1) or Class 2 (C2) review, Jang said, “Our case is a C2.”
According to Jang, the C2 criterion is based on whether the FDA needs to request additional security and efficacy data, which would require more time for review.
“In this case, it was C2 because the FDA requested a re-inspection of the production site,” Jang said, emphasizing that the review focused on the production facility without requiring additional clinical studies or data submissions.
Jang also clarified that some media reports citing the need for additional clinical studies were inaccurate, stating that “no additional clinical trials are required.”
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