A government advisory panel unanimously approved an experimental drug, Adcetris, from Bothell, WA.-based drug maker, Seattle Genetics, serving as the company's first commercial drug approved by the U.S. Food and Drug Administration.
The FDA's 10-member Oncologic Drug Advisory Committee panel voted to approve the chemotherapy drug, which targets Hodgkin lymphoma, a cancer of the white blood cells that has also been found useful for treatment of recurring large-cell lymphoma, based on a single study in about 100 patients, the Associated Press reported.
The drug - generic name of brentuximab vodotin and a proposed brand name of Adcetris - is designed to deliver chemotherapy directly to cancerous tumor cells, sparing healthy cells, and is for patients whose cancer has not responded to other drugs or has returned.
The FDA, which has not approved a new drug for Hodgkin lymphoma since 1977, can weigh the panels' decision but does not have to follow their advice. Although, there is no strict deadline set, a decision is expected to be made in August. According to the National Cancer Institute, there were 8,490 new cases of the disease in the United States in 2010 and 1,320, which resulted in death.
This drug has extremely exciting activity and is a great example of the kind of drug that should go ahead with accelerated approval, panel chair Dr. Wyndham Wilson of the National Cancer Institute told reporters. 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.
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. Howard Liang, an analyst at Leerink Swann, sees U.S. sales at over $400 million for both types of cancer in 2015.
According to Liang, Seattle Genetics shares hit an all-time high of $21.41 on June 28 after European health regulators accepted an application to market the drug for both Hodgkin's and ALCL in Europe. The stock is down probably because there are some hints the FDA may not allow as broad a label as the company is seeking, Liang told Reuters.