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Originally published May 2, 2011 at 8:25 AM | Page modified May 2, 2011 at 7:13 PM

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Seattle Genetics says FDA is reviewing cancer drug

Seattle Genetics said Monday that the Food and Drug Administration is now reviewing its experimental cancer drug as a treatment for Hodgkin's disease and a type of lymphoma.

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Seattle Genetics said Monday that the Food and Drug Administration is now reviewing its experimental cancer drug as a treatment for Hodgkin's disease and a type of lymphoma.

The Bothell company said the FDA will make separate decisions on the two applications by Aug. 30. Seattle Genetics filed for marketing approval of the drug, called brentuximab, as a treatment for patients whose cancer did not respond to other drugs or has returned after previous treatment.

Hodgkin's disease and systemic anaplastic large cell lymphoma are both rare cancers that affect the lymphatic system.

While both are treatable with chemotherapy, Seattle Genetics said the large portion of patients who do not respond to chemotherapy have few other treatment options.

The company said the brentuximab will receive orphan drug status as a treatment for both cancers, meaning that if it is approved, the company will have up to seven years of marketing exclusivity. Orphan drug status is given to treatments for rare diseases and to diseases that have few available treatments.

Seattle Genetics says brentuximab vedotin targets a protein found in Hodgkin's disease and other T-cell cancers and blood cancers.

The company is developing the drug with Millennium Pharmaceuticals, a unit of Japanese drugmaker Takeda. The companies are sharing development costs in most countries.

Seattle Genetics holds the U.S. and Canadian marketing rights, and Takeda has the right to sell the drug in the rest of the world. Takeda is solely responsible for development of brentuximab in Japan.

The FDA is conducting a six-month priority review of the drug, as Seattle Genetics filed for approval at the end of February.

The company said 8,500 people in the U.S. were diagnosed with Hodgkin's disease in 2010, and it said about 30 percent of patients relapse or don't respond to primary chemotherapy. Systemic ALCL is an aggressive type of non-Hodgkin's lymphoma diagnosed in about 2,000 people a year in the U.S. Seattle Genetics said about half of all patients relapse or don't respond to chemotherapy.

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