FDA okays first new lymphoma drug since 1977: Will Adcetris help?
(CBS/AP) A new cancer drug won approval from the FDA, bringing hope to sufferers of two rare blood cancers who fail other treatments.
On Friday the FDA approved Adcetris for treating Hodgkin's lymphoma and systemic anaplastic large cell lymphoma. Adcetris delivers the drug directly to cancerous cells using a targeted antibody, leaving healthy cells untouched.
The injectable drug is approved for patients who weren't successful treating their disease with a bone marrow transplant or multiple chemotherapy rounds.
Adcetris is the first drug approved for the Hodgkin's lymphoma since 1977. The FDA sped approval up under an accelerated, six month system reserved for therapies that show promising results in early studies.
A study of 102 patients with Hodgkin's lymphoma showed 73 percent of patients taking Adcetris saw their tumors shrink or disappear completely. On average, these patients responded to the drug for more than six months. 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.
But the FDA's accelerated approval program has met criticism in the last year after multiple follow-up studies showed popular breast cancer drug Avastin did not extend patient's lives. The FDA accelerated approval for that indication based on a single study, and are now in the process of trying to remove the drug's indication.
Seattle Genetics said it's working with the FDA on follow-up trials to confirm the results.
About 8,800 new cases of Hodgkin's disease are diagnosed each year. Hodgkin's is a cancer of lympth tissue found in the lymph nodes, spleen, liver and bone marrow. Symptoms include fatigue, fever, chills, unexplained itching, painful swelling of lymph nodes, and weight loss.
Anaplastic large cell lymphoma is a rare type of non-Hodgkin's lymphoma, making up only 3 percent of the 66,000 cases of non-Hodgkin's diagnosed each year. Symptoms include weight loss, night sweats, enlarged lymph nodes throughout the body - especially in the neck or armpits.
The Lymphoma Research Foundation has more on these diseases.
