Seattle Genetics Inc. has finally obtained the U.S. Food and Drugs Administration (FDA) nod for a second type of blood cancer drug. The FDA advisory committee voted 10-0 on Thursday to recommend accelerated approval of the drug, under the proposed trade name Adcetris, for anaplastic large cell lymphoma (ALCL). The panel earlier unanimously approved the drug for Hodgkin's lymphoma, another type of blood cancer.
Dr. Wyndham Wilson of the National Cancer Institute – the panel chair said, “This drug has extremely exciting activity and is a great example of the kind of drug that should go ahead with accelerated approval.”
This new drug is meant for ALCL patients already treated for the disease. About 2,000 new cases of ALCL were diagnosed in 2010, according to the company. Regular drug approval normally requires two late-stage trials for each indication. The FDA is not required to follow the group's advice, though it usually does. The FDA is due to make a final decision for both indications of the drug by August 30.
Adcetris uses a targeted antibody designed to deliver chemotherapy directly to cancerous tumor cells, sparing healthy cells. If the drug is ultimately approved, Seattle Genetics will market it in the U.S. and Canada while Takeda Group will hold marketing rights for the rest of the world. Adcetris would be the first Seattle Genetics drug to reach the market.
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