Tanja Obradovic: Replimune PDUFA for RP1 Did Not Go Well
Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared on LinkedIn:
“Replimune PDUFA for RP1 not go well with FDA issuing CRL
In my post prior to PDUFA pointed to an uphill challenge based on what 1/2 Phase IGNYTE trial can deliver. CRL highlighted several issues that highlight critical aspects of running early oncology combination trials with intention to file.
Two stand out -need for control arm and evaluation of the contribution to effectiveness of backbone (in this case Nivolumab) and patient population heterogeneity.
Company will be meeting with FDA to discuss path forward and several scenarios around trial design and pipeline come to mind. For melanoma-treating community of patients, providers and Pharma will be closely following developments to see where future steps land.”
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