OncoGenex Cancer Drug (NASDAQ:OGXI)

OncoGenex Pharmaceuticals Inc has recently announced that the Food and Drug Administration panel has approved their additional fast-track designation to their new prostrate cancer drug, OGX-011, in combination with the first-line chemotherapy. The news about the approval of cancer drug by FDA sent OncoGenex Pharmaceuticals’ shares up on the market charts. This fast-track designation is structured to expedite the review of drugs used for the treatment of serious disease and to fill in unmet medical needs. Most of the drugs that are eligible for the designation are likely to receive a priority review. It is easier for the FDA to make their decisions quickly to approve drugs once they have received a priority review.

OncoGenex Pharmaceuticals have already received a fast-track status for second-line treatment with their OGX-011 in combination with Docetaxel, a chemotherapy drug. This will be used for treatment of progressive metastatic prostrate cancer. In June this year, OncoGenex had reached an agreement with the FDA through special protocol assessment process to make changes to the design of a late stage-trial of OGX-011.

The fast-track designation was based on the data from the mid-stage study that showed that the new drug in combination with docetaxel treatment may improve the survival rate in patients suffering from prostrate cancer.