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Rp1

All articles tagged with #rp1

healthcare1 hour ago•6 min saved

Advisory panel backs Replimune’s RP1 for melanoma despite data questions

An FDA advisory committee voted 10-3 in favor of Replimune’s RP1 oncolytic virus (with Opdivo) for advanced melanoma, citing signs of efficacy despite significant trial-design concerns that the FDA flagged (no control arm, RECIST deviations, reinjection artifacts). While some data hint at systemic activity, the panel stressed uncertainty and noted the ongoing Ignyte-3 phase 3 data as pivotal; the FDA decision on RP1 is expected by August 2 amid a large unmet need for refractory melanoma treatments.

via Fierce Biotech|

#fda-advisory-committee #healthcare #ignyte

business3 months ago•2 min saved

FDA again blocks Replimune’s melanoma program, casting doubt on RP1’s future

The FDA rejected Replimune’s RP1 melanoma candidate for a second time, citing that the Ignyte trial data do not show substantial evidence of effectiveness and that new trial data are unpersuasive (only about 10% of planned patients treated and no prespecified progression-free survival data). The agency’s ruling leaves RP1’s future uncertain and prompted a roughly 20% drop in Replimune’s stock.

via Fierce Biotech|

#business #fda #melanoma