Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)
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Amgen (AMGN) Announces Receipt of Positive EMA CHMP Opinion for IMLYGIC in Unresectable Melanoma
October 23, 2015 7:23 AM EDTAmgen (NASDAQ: AMGN) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.
IMLYGIC, administered via intralesional injection,... More
