FRANKFURT (Reuters) Sept 20 - The U.S. Food and Drug Administration (FDA) has approved the use of leukemia drug Campath to newly diagnosed patients, Bayer and Genzyme Corp said on Thursday.
The product is currently approved to treat B-cell chronic lymphocytic leukemia, or B-CLL, in patients who have failed two types of treatment.
"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, lead investigator of the pivotal study comparing Campath against chlorambucil.
Gunnar Riemann, a board member of Bayer Schering Pharma, said the ability to use Campath earlier for patients would make an important difference in battling leukemia.
"It may help patients by offering a potentially more effective treatment approach that can extend progression-free survival," Riemann said.
According to the Leukemia and Lymphoma Society, about 15,000 new cases of B-CLL are diagnosed in the United States each year. It is the largest subset of chronic lymphocytic leukemia, the most common form of adult leukemia in the western world.
Campath is known outside the United States as MabCampath and is marketed by Germany's Bayer Schering Pharma AG. It is marketed in the United States by Bayer AG's U.S. affiliate, Bayer HealthCare Pharmaceuticals.
Genzyme makes the drug and Bayer markets it under a licensing agreement with Genzyme.
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