Pfizer will pull ineffective leukemia drug (more deaths among patients taking the drug)

[Robbien]

The Food and Drug Administration cleared the drug Mylotarg in 2000 under its accelerated approval program, which grants speedy access to drugs that show early promise. The drug was cleared for patients older than 60 with relapsed acute myeloid leukemia, a bone marrow cancer.

But the FDA said a follow-up study was halted last August after researchers reported more deaths among patients taking Mylotarg plus chemotherapy, compared with chemotherapy alone.

The study was intended to show that adding Mylotarg to chemotherapy increased lifespan, which it failed to do.

Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market.

. . .

Dr. Mikkael Sekeres of the Cleveland Clinic said the drug caused disease remission in about 25 to 30 percent of his patients. However, he noted that the drug's benefits came with increased toxicity, which can be fatal.

"What is concerning is that it took this long to come up with a confirmatory study for a drug that was approved," based on preliminary data, said Sekeres, director of Cleveland Clinic's leukemia program.

The confirmatory study was begun in 2004, four years after the drug was approved.

Last year the Government Accountability Office reported more than one-third of the studies FDA has required under its accelerated approval program are still pending. The GAO's investigators said the FDA does not rigorously track whether companies are making progress on their required studies.

http://finance.yahoo.com/news/FDA-Pfizer-will-pull-apf-2561904435.html?x=0&sec=topStories&pos=main&asset=&ccode=

Ineffective is an understatement. May cure the cancer but will kill the patient's liver.