The FDA has issued a whole response letter to Replimune indicating it’s unable to approve the biologics license utility for vusolimogene oderparepvec together with nivolumab for the therapy of superior melanoma.
Based on an organization press launch, the letter signifies that the FDA can’t approve the applying for vusolimogene oderparepvec (RP1) — the corporate’s lead product candidate — in its present kind, stating the IGNYTE trial “is just not thought of to be an sufficient and well-controlled medical investigation that gives substantial proof of effectiveness.”
The FDA additionally cited issues in regards to the heterogeneity of the trial’s affected person inhabitants and gadgets associated to the confirmatory trial examine design. Nonetheless, the company didn’t point out issues of safety.
“We’re stunned by this FDA resolution and dissatisfied for superior melanoma sufferers who’ve restricted therapy choices as highlighted by the granting of breakthrough standing on the time we supplied the IGNYTE major knowledge,” Sushil Patel, PhD, Replimune’s CEO, stated within the launch. “The problems highlighted within the [complete response letter] weren’t raised by the company through the mid- and late-cycle critiques. Moreover, we had additionally aligned on the design of the confirmatory examine.
“We strongly consider that RP1 together with nivolumab can convey substantial profit to superior melanoma sufferers,” he added.
Replimune will request a Sort A gathering with the FDA, which it expects to be granted inside 30 days, and can proceed its efforts towards accelerated approval for vusolimogene oderparepvec.
