FDA hands another rejection to Replimune's melanoma therapy Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.

#Replimune has had its #advancedmelanoma treatment #RP1 turned down by the #FDA for a second time, a decision that has led the company to accuse the agency of inconsistencies in its review of the drug.

pharmaphorum.com/news/fda-han...

Scancell points to 'strong' melanoma vaccine data Scancell has the results it was hoping for with its melanoma immunotherapy iSCIB1+ and is accelerating plans for a pivotal trial.

#Scancell #NationalCancerInstitute #UKbiotech #DNAplasmidvaccine #melanoma #SCOPEtrial #SCIB1 #iSCIB1+ #checkpointinhibitortherapy #advancedmelanoma #immunotherapy #melanomaantigens #TRP2protein #Tcells #checkpointinhibitors #metastaticmelanomatreatment
pharmaphorum.com/news/scancel...

Replimune receives CRL on BLA for RP1 for advanced melanoma Replimune has announced that the FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 in combination with nivolumab for the treatment of advanced melanoma.

#Replimune has announced that the #FDA has issued a #CRL regarding the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of #advancedmelanoma.

pharmaphorum.com/news/replimu...

#ClinicalTrial EA6192/PET-Stop is a phase II study investigating how well biomarkers on PET/CT imaging can drive early discontinuation of anti-PD-1 therapy in patients with #AdvancedMelanoma . More info here: bit.ly/ea6192pet