With the Food and Drug Administration's advisory panel backing Arzerra, - the proposed leukemia treatment to be marketed by the UK-based GlaxoSmithKline PLC, and developed by its Denmark-based partner Genmab - the therapy has moved a step closer to its approval, the decision about which will come by July 30.
The panel's 10 to 3 voting in favor of the Glaxo-Genmab cancer drug amounts to its recommendation for the drug's FDA approval. As per the outside medical experts comprising the panel, the response rates seen in Arzerra's clinical study are "reasonably likely to predict clinical benefit." However, the three panel members, voting against the drug opine that the FDA should wait for further studies to corroborate the advantages of the drug.
Elaborating that Arzerra is a prospective treatment for patients who have either fail to respond to other treatments or who otherwise cannot use standard therapies, Dr. Debasish Roychowdhury - Glaxo's head of medicines development in its oncology unit - said that the panel's vote in favor of Arzerra is a "potential milestone" for patients with chronic lymphocytic leukemia (CLL).
Since CLL results from abnormal production of white body cells in the body, Arzerra attaches itself to a protein called CD20, present on the surface of most white blood cells, and helps in destroying the cell by signaling the body's own immune system to exterminate it!
(via TopNews United Kingdom. Contributed by Sudhanshu Kashyap)
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