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FDA Panel Backs Allos Therapeutics' Cancer Drug (10764)

Thu, 09/03/2009 - 4:56am
WASHINGTON (AP) — Federal health experts voted Wednesday in favor of an experimental cancer drug from Allos Therapeutics for patients with a rare form of cancer. A spokeswoman for the Food and Drug Administration said the agency's panel of oncology experts voted 10-4 that the company's drug pralatrexate would likely benefit patients with T-Cell lymphoma. The FDA is not required to follow the group's advice, though it often does. T-cell lymphoma is a type of cancer that attacks the immune system. There are currently no FDA approved treatments for the disease. Westminister, Colo.-based Allos has asked the FDA to approve its drug for patients whose cancer reoccurs or has not responded to other drugs. Company studies of the drug showed 27 percent of patients with T-Cell lymphoma responded to treatment, with more than half responding for about three months. Panelists said the results suggest the drug could increase overall survival for T-cell Lymphoma patients, adding that new treatments are needed for the disease. The FDA is scheduled to make a decision on the drug by Sept. 24. "We are very pleased that the advisory committee today voted to recommend accelerated approval of the Folotyn NDA," said Paul L. Berns, CEO at Allos Therapeutics, in a statement. "We believe Folotyn has the potential to offer an important new treatment option for patients with relapsed or refractory PTCL, an indication for which there are currently no FDA-approved therapies and no accepted standard of care."
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