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FDA Approves Seattle Genetics’ Adcentris
August 19, 2011
The Food and Drug Administration approved Adcentris, from Seattle Genetics, to treat Hodkin lymphoma and anaplastic large cell lymphoma. It is the first new treatment for Hodgkin lymphoma in 34 years. The FDA’s press release can be found here.
The drug was granted accelerated approval, meaning that additional studies will be needed to confirm its efficacy. The product label is also relatively limited. In Hodkin lymphoma, the drug’s use is recommended only after a stem cell transplant, a grueling procedure in which the blood-producing stem cells in the bone marrow are replaced, or after two rounds of chemotherapy in patients who are not going to be able to get a stem cell transplant. It is recommended after one course of chemotherapy in patients who have ALCL. Seattle Genetics shares rose 4% to $14.50 on the news.
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