WASHINGTON (AP) — A novel cancer drug intended to treat two unusual cancers that attack the lymph nodes has been approved by the United States Food and Drug Administration.
Seattle Genetics Inc.’s Adcetris has received FDA approval for Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. Adcetris ensures direct drug delivery to cancer cells by means of a targeted antibody, thereby sparing healthy cells.
The drug has been approved by the US regulators for those patients who have already undergone a bone marrow transplant or multiple chemotherapies for treating their cancer.
The National Cancer Institute estimates nearly 8,800 new diagnoses of Hodgkin’s disease for 2011. Ever since 1977, Adcetris is the first drug to have received approval for this indication.
The FDA granted fast-track approval for Adcetris within six months, a system set aside for medications that show promising early results.
The study involved 102 Hodgkin’s lymphoma patients, of whom 73% experienced a complete tumor shrinkage or disappearance with the drug. These patients also responded to therapy for over 6 months, on average.
The large cell lymphoma study involved 58 patients, of whom 86% responded to the drug therapy for over a year, on average.
The expedited approval system by the FDA has been subjected to criticism in the previous year because multiple follow-up studies demonstrated that Avastin (a popular caner drug) failed to prolong survival in several breast cancer patients. Avastin had received expedited FDA approval based on a single breast cancer study. Although the FDA is now in the process of eliminating the drug’s indication, the drugmaker Roche has appealed the decision.
Seattle Genetics stated that it is working with the FDA to establish the benefits of Adcetris through follow-up trials.
The injectable drug will be marketed in the U.S. and Canada by the Seattle-based biotech drugmaker, while marketing in the rest of the world will be taken care by the Takeda Group.
In afternoon trading, Seattle Genetics shares hiked 41 cents, or 2.9 percent, to $14.36.