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FDA is reviewing Seattle Genetics drug

Seattle Genetics Inc. said Monday 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 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.

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