(RxWiki News) The Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) has voted unanimously to recommend that the FDA grant accelerated approval of Adcetris (brentuximab vedotin).
Adcetris treats patients with Hodgkin lymphoma who have relapses after a stem cell transplant. The committee also recommended approval of the drug to treat relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).
"Lymphoma patients may soon have new treatment options."
The drug is known as an antibody-drug conjugate (ADC) that targets a marker of Hodgkin lymphoma and ALCL called CD30.
The ODAC's recommendations are based on two trials investigating its impact on both diseases. The FDA is not obligated to agree with this recommendation.
As a targeted therapy Adcetris goes after and kills only the cancerous cells containing the CD30, while sparing the healthy cells. This mechanism offers a potentially more powerful effect on the tumor, while minimizing toxicity.
Adcetris is being developed Seattle Genetics in collaboration with Millennium: The Takeda Oncology Company. The drug is currently being reviewed by the European Medicines Agency.
The FDA is expected to make its final decision on approval by August 30, 2011.
Lymphoma refers to a group of cancers that start in the lymphatic system. The major types of the disease are Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other forms of the disease by the presence of what's known as the Reed-Sternberg cell, which expresses the CD30 antigen. An antigen is seen by the body as a foreign invader.
Anaplastic large cell lymphoma - ALCL - is an aggressive kind of non-Hodgkin lymphoma that expresses a high level of CD30.
According to the American Cancer Society,an estimated 8,800 cases of Hodgkin lymphoma and about 2,000 cases systemic ALCL will be diagnosed in the United States in 2011.