CEL-SCI to pursue Canada’s conditional approval route for Multikine to treat HNC

CEL-SCI Corporation announced it has held a productive pre-submission meeting with Canada’s regulator to determine the best regulatory path toward market approval. Based on the existing data that was summarized and presented, Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions policy. Additional discussions explored how patients at lower risk for recurrence could be targeted for treatment, and what sort of post-market commitments could help ensure that only the most suitable patients would be treated with Multikine, based on the best available evidence. "The Notice of Compliance with Conditions" policy facilitates earlier access for physicians and patients to promising new drugs for patients suffering from serious, life-threatening or severely debilitating diseases. Acceptance of promising evidence of clinical effectiveness of Multikine as an initial therapy for patients with advanced primary head and neck cancer would allow for the filing of an eligible drug submission earlier than normally possible because it promises to fulfil an unmet medical need," stated CEL-SCI CEO, Geert Kersten. "We continue to prepare our Biologics License Application for U.S. FDA approval, while also pursuing marketing approval in other countries." Canada was one of over 20 countries in which CEL-SCI’s global pivotal Phase 3 IT-MATTERS study enrolled a total of 928 head and neck cancer patients,locally advanced primary squamous cell carcinoma of the head and neck .