New Lymphoma Drug Awaiting Approval


According to a report issued this past Monday, the Food and Drug Administration (FDA) is now reviewing Seattle Genetics Inc.’s experimental cancer treatment for Hodgkin’s disease and a type of lymphoma.

As per the company’s announcement, the FDA will make separate, unrelated decisions on the two applications by August 30. This, of course, comes on the heels of Seattle Genetics filing for marketing approval of the drug brentuximab for the purposes of treating patients whose cancer didn’t respond to other forms of drugs.

Both Hodgkin’s disease and systemic anaplastic large cell lymphoma are extremely rare disorders that impact the lymphatic system. Both can be treated with chemotherapy; however, in the event that chemotherapy does not work, sufferers have few alternative options to turn to.

Brentuximab, however, is going to receive orphan drug status as a means of treating both types of cancers. Essentially, if approved, the company will have the opportunity to utilize up to seven years of marketing exclusivity.

Seattle Genetics is developing the drug in a joint effort with Millennium Pharmaceuticals, a unit of Japanese drug maker Takeda.

Currently, the FDA is conducting a six-month priority review of the drug.

According to Seattle Genetics, 8,500 people in the U.S. were diagnosed with Hodgkin’s disease in 2010. Further, the same records indicate that 30 percent of the patients relapse or don’t respond to chemotherapy.

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