Article
Amgen's T-Vec to Receive FDA Decision Today
Author(s):
The vaccine, approved in Europe last week, is now awaiting approval in the United States.
Imlygic, or talimogene laherparepvec, a genetically modified herpes simplex type 1 virus developed by Amgen to be injected directly into tumors, where it replicates and forces tumor cell rupture, is waiting for FDA's decision. The NDA for this virus-based treatment has been submitted for melanoma.
An advisory panel for the FDA reviewed data from the phase 3 OPTiM trial and voted 22-1 in favor of approval back in April 2015. Now the FDA has to consider this panel's advice before it's decision later today.
Meanwhile, the European Medical Agency approved T-Vec for use in patients with unresectable melanoma that has not metastatized just last week.
Read more here.
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