UPDATE 1-EU agency backs Bayer, Genzyme leukemia drug

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FRANKFURT Oct 23 (Reuters) - The European Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of leukaemia drug alemtuzumab to newly diagnosed patients for whom certain chemotherapy treatment is not appropriate.

Recommendations for marketing approval by CHMP are normally endorsed by the European Commission within a couple of months.

Genzyme GENZ.O makes the drug, known in the United States as Campath and outside the United States as MabCampath. Bayer BAYG.DE markets it under a licensing agreement with Genzyme.

MabCampath is currently approved to treat B-cell chronic lymphocytic leukaemia, or B-CLL, in patients for whom two other treatments have not worked.

Bayer shares were up 1.4 percent at 58.95 euros at 0900 GMT, compared with a 0.5 percent gain in the German blue-chip DAX .GDAXI index.

Gunnar Riemann, a Bayer Schering Pharma board member, said the recommendation underscored MabCampath's potential to become a standard of care for patients.

"We believe that therapy with MabCampath earlier in the course of treatment represents a significant advance for B-CLL patients," Riemann said.

Last month, the U.S. Food and Drug Administration (FDA) approved the use of Campath to newly diagnosed patients.

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.

According to the Leukaemia 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 leukaemia, the most common form of adult leukaemia in the western world.

The CHMP's opinion was based on data from a late study comparing MabCampath with chlorambucil in previously untreated B-CLL patients.

The study met its primary endpoint by demonstrating superior progression free survival in patients, with MabCampath reducing the risk of disease progression or death by 42 percent.