Jeannie Hou, Senior Vice President Clinical Development at Replimune, shared a post by FDA on LinkedIn, adding:
“Big step for melanoma patients, clinicians, Replimune and the FDA today. Thank you to all our investigators and patients on the IGNYTE study. Looking forward to the completion of the ongoing IGNYTE-3 study.”
Quoting FDA:
“Today, FDA granted approval to a genetically modified oncolytic viral therapy for the treatment of adults with unresectable advanced cutaneous melanoma whose disease has progressed after treatment with a PD-1-blocking antibody-based regimen. Anti-PD-1 refractory melanoma is an advanced form of skin cancer that no longer responds to a widely used class of immunotherapy. As the disease develops mechanisms to evade the immune system, treatment options become increasingly limited.
This approval reflects the FDA’s longstanding commitment to using every available regulatory tool to help bring meaningful new treatment options to patients with serious diseases while ensuring therapies meet the agency’s standards for safety and effectiveness. Learn more about this accelerated approval and what it means for patients and providers.”
You can also read:
Third Time’s the Charm: FDA Approves Replimune’s Tudriqev (RP1) for Advanced Melanoma