FDA Panel Unanimously Favors Accelerated Approval for Seattle Genetics' Drug
A panel of federal cancer experts has unanimously voted to grant accelerated approval to Seattle Genetics' (Nasdaq:SGEN) innovative chemotherapy drug to treat patients with recurring Hodgkin's disease, a cancer of the white blood cells.
All 10 members of the Food and Drug Administration's oncology drug panel voted in favor of approving the drug based on a single study in about 100 patients. Regular approval normally requires two trials. The FDA is not required to follow the group's advice, though it usually does.
"This drug has extremely exciting activity and is a great example of the kind of drug that should go ahead with accelerated approval," said panel chair Dr. Wyndham Wilson of the National Cancer Institute.
The company has submitted its drug, called Adcetris, as a treatment for patients whose cancer has not responded to other drugs or has returned.
Hodgkin's disease and systemic anaplastic large cell lymphoma are both rare cancers that affect the lymphatic system. The panel will vote separately on the use for lymphoma later this afternoon.
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.
Shares of Seattle Genetics Inc., based in Bothell, Wash., were halted in trading ahead of the panel vote.
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