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FDA OKs accelerated approval to twice-rejected Tudriqev with Opdivo for advanced melanoma
The FDA has granted accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a prior anti-PD-1 therapy.The approval for vusolimogene oderparepvec-wtpg (Tudriqev, Replimune) — an oncolytic immunotherapy previously called RP1 — comes after two prior rejections
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biopharmadive.com
Replimune rebounds to win FDA approval of melanoma drug
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed the arguments of FDA scientists.
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medpagetoday.com
FDA Finally OKs Twice-Rejected Melanoma Drug
Approved in combination with nivolumab for patients who progress on prior anti-PD-1 therapy
