Replimune Group, Inc., a clinical stage biotechnology company, has scheduled a Type A meeting with the FDA to discuss the complete response letter for RP1 in combination with nivolumab for the treatment of advanced melanoma.
The Company submitted a briefing book addressing the points from the CRL and highlighting agreements related to patient population criteria and trial design.
CEO Sushil Patel emphasized the urgent need for access to RP1 based on data strength and limited treatment options for advanced melanoma patients.
Type A Meeting Scheduled
Scheduled meeting with the FDA to discuss the complete response letter for RP1 in combination with nivolumab for advanced melanoma treatment.
Briefing Book Submission
Company submitted a briefing book addressing CRL points, patient population criteria, and trial design agreements.
CEO's Commitment
CEO Sushil Patel commits to patient access and regulatory approval for RP1 in advanced melanoma treatment.
- The Type A meeting with the FDA signifies a crucial step towards resolving issues highlighted in the complete response letter.
- Engagement with leading physicians and patient advocacy groups underscores the importance of swift approval for RP1 in treating advanced melanoma.
Replimune remains dedicated to transforming cancer treatment through innovative oncolytic immunotherapies with a focus on maximizing tumor killing potency and systemic anti-tumor immune response.