In early July 2013 we wrote this article, “Investigational Mesothelioma Treatment VS-6063 From Verastem Granted Orphan-Drug Status In European Union”, which gave us hope there might be a new treatment for mesothelioma. The problem was, however, that this VS-6063 experimental cancer drug was not available to patients in the U.S.
We are glad to report, now, that Veristem has received FDA permission for VS-6063 to move forward and possibly be used to treat mesothelioma patients here.
From this recent news report “Verastem gets orphan drug designation in the U.S.”:
The designation for VS-6063 as a treatment for mesothelioma could mean a faster approval process for the drug and a longer period before competition from generic versions of the drug. It is granted to investigational drugs that address rare diseases for which there is no current treatment.
The Cambridge, Mass., biotech [company Verastem Inc.] develops cancer drugs that work by targeting cancer stem cells. VS-6063 was acquired a year ago from Pfizer after it had already undergone Phase 1 trials to test for safety against several types of cancers. Verastem since discovered it to be effective against mesothelioma, a cancer for which there is only one approved treatment in the U.S.
“Mesothelioma is among the most aggressive and lethal cancers but has limited treatment options,” said [Verastem] President and CEO Robert Forrester in a statement. “We are pleased that the FDA recognizes the significant unmet medical need in mesothelioma.”
Verastem is currently involved with a Phase 1 clinical trial for VS-6063 and has plans for a Phase 2 trial later this year as it takes the necessary procedural and scientific steps towards getting this new cancer drug approved by the FDA as a second mesothelioma treatment here in the U.S.
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