The FDA has issued a Complete Response Letter (CRL) to Replimune Group concerning its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) combined with nivolumab for treating advanced melanoma. The agency raised concerns about the Phase I/II IGNYTE trial, stating it was not adequately controlled and had a diverse patient group, making interpretability challenging. Despite no identified safety issues, the FDA highlighted issues with the trial design.
Replimune’s CEO, Sushil Patel, expressed surprise and disappointment at the decision but remains committed to advancing treatment options for melanoma patients. Following this setback, Replimune has launched the Phase III IGNYTE-3 trial to further evaluate RP1’s efficacy in combination with nivolumab. This regulatory hurdle faced by Replimune is not unique, as Capricor Therapeutics recently encountered a similar setback with its cell therapy for Duchenne muscular dystrophy. The FDA’s move towards greater transparency by publishing CRLs from recent years aims to provide more insight into regulatory challenges faced by biotech companies. Replimune plans to engage in discussions with the FDA to chart a path towards accelerated approval for RP1 in combination with nivolumab.
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