WASHINGTON (AP) — Federal regulators have approved an innovative cancer drug from Seattle Genetics Inc. to treat two rare forms of cancer that attack the lymph nodes.
The Food and Drug Administration on Friday approved Adcetris to treat Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. Adcetris uses a targeted antibody to deliver the drug directly to cancerous tumor cells, sparing healthy cells.
The FDA approved the drug for patients who have already tried treating their disease with a bone marrow transplant or multiple rounds of chemotherapy.
About 8,800 new cases of Hodgkin’s disease are expected to be diagnosed this year, according to the National Cancer Institute. Adcetris is the first drug approved for the disease since 1977.
The FDA approved the drug under an accelerated, six month system reserved for therapies that show promising early results.
In a study of 102 patients with Hodgkin’s lymphoma, 73 percent of patients taking the drug saw their tumors shrink or disappear completely. On average, these patients responded to the drug for more than six months.
The approval for large cell lymphoma was based on a 58 patient study in which 86 percent of patients responded to the drug for over one year, on average.
The FDA’s accelerated approval program has come under criticism in the last year after multiple follow-up studies showed the popular cancer drug Avastin did not extend the lives of patients with breast cancer. The FDA granted the drug accelerated approval for that indication based on a single study. The FDA is now in the process of trying to remove the drug’s indication. The drug’s maker, Roche, has appealed the decision.
Seattle Genetics said in a statement it is working with the FDA on follow-up trials to confirm the benefits of Adcetris.
The Seattle-based biotech drugmaker will market the injectable drug in the U.S. and Canada, while Takeda Group holds marketing rights for the rest of the world.
Shares of Seattle Genetics rose 41 cents, or 2.9 percent, to $14.36 in afternoon trading.
