UPDATE 1-Bayer, Genzyme get OK for wider leukemia drug use

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FRANKFURT, Sept 20 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved the use of leukemia drug Campath to newly diagnosed patients, Bayer BAYG.DE and Genzyme Corp GENZ.0 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.

B-CLL is a type of blood cancer in which too many white blood cells collect in the bone marrow, blood and other organs of the body. They cause infection because they force out healthy cells as these sick cells live longer than normal ones.

Bayer shares were little changed after the announcement, down 0.2 percent at 58.40 euros at 1230 GMT, broadly in line with the German blue-chip DAX .GDAXI index.

"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. Genzyme acquired Campath when it bought Ilex Oncology in 2004.

Bayer and Genzyme are developing Campath in oncology, multiple sclerosis and other indications.