Folotyn drug gets FDA approval (Nasdaq:ALTH)

By Jyotsna Ramani on 09/28/2009 – 10:10 am PST -- Biotech

Allos Therapeutics Inc (Nasdaq:ALTH) must be delighted with joy after getting a green signal by the FDA panel for their injectable drug Folotyn, which will be used for the treatment of peripheral T-cell lymphoma, a rare kind of aggressive lymphatic cancer. The news came in early morning on 25th September, 2009 when FDA advisory panel approved Allos’ Folotyn cancer drug based on patient’s overall response rate.  The great news is that it’s the first and the only drug approved for PTCL (Peripheral T-Cell Lymphoma), a form of blood cancer.

The news had a catalyst effect on the stock market and in no time Allos Therapeutics’ shares went up high which provide a great boost to Allos Therapeutics. In the morning trading, shares of Allos Therapeutics went up 4.3 percent and closed at $8.50. The company has said that Food and Drug Administration of the United States of America has granted them with accelerated approval, which will allow Allos Therapeutics to market Folotyn to use in patients whose cancer has not responded to earlier treatments. The company said that they will market Folotyn soon and the drug should be available in the market by October 2009.

Members of the FDA advisory panel said that the approval was accelerated because currently there are no treatments for patients suffering from PTCL and hence the decision had to be taken quickly. It is also been said that the FDA approved Folotyn because they saw that the patients treated with Folotyn had their tumors shrink considerably which made it easier for FDA to approve Folotyn in such a short span of time. FDA panel has further stated that Allos Therapeutics will conduct additional clinical trials to further define the benefits of Folotyn and whether Folotyn can extend survival.

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