UPDATE 2-US FDA panel backs Bristol-Myers leukemia drug

 

ATLANTA, June 2 (Reuters) - An experimental Bristol-Myers Squibb Co. (BMY.N: Quote, Profile, Research) pill should be approved for treating some types of leukemia in patients who have few if any other options, a U.S. advisory panel said on Friday.

The drug called Sprycel reduced or eliminated leukemia cells in some patients who had stopped responding to Novartis AG's (NOVN.VX: Quote, Profile, Research) (NVS.N: Quote, Profile, Research) drug Gleevec or could not tolerate it, advisers to the Food and Drug Administration agreed.

The only option for many patients at that stage is to undergo a risky bone-marrow transplant, if they are eligible.

Sprycel's potential to halt a deadly cancer outweighed the risks of serious side effects such as internal bleeding or fluid retention, panel members said.

"The drug is more complicated to give than (Gleevec) ... That said, I think it's clear that the risk/benefit is far in favor of the benefit," said Dr. Ellin Berman, a panel member and leukemia expert at Memorial Sloan-Kettering Cancer Center.

The FDA usually follows advice from its outside advisory panels. A final FDA decision is expected by June 28.

Gleevec has produced dramatic results putting chronic myeloid leukemia (CML) into remission for up to five years, but some experts estimate 20 percent of patients do not respond to it or develop resistance.