The FDA designates the combination of Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and Eisai’s (OTCPK:ESALY) Lenvima (lenvatinib) a Breakthrough Therapy for the first-line treatment of advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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