Mylotarg: This Cancer Drug Kills Four Times More than No Treatment at All
July 06, 2010
Drugmaker Pfizer is pulling Mylotarg, a decade-old leukemia medicine, off the U.S. market after a study found a higher death rate and no benefit for patients.
Mylotarg won approval under an abbreviated process. Medicines cleared in that way have to pass follow-up tests to confirm they work. The FDA asked Pfizer to withdraw the drug after a recent clinical trial raised concerns about the product's safety and clinical benefits.
"The trial ... showed more deaths in the first couple months of treatment. The fatality rate was 5.7 percent for Mylotarg patients, compared with 1.4 percent without the drug, Pfizer said. Mylotarg is the first drug approved under the FDA's abbreviated process to be withdrawn for failing to show effectiveness, agency officials said."
Pfizer, the world's biggest drugmaker, has also suspended trials of an experimental pain relief drug for osteoarthritis, Tanezumab, after reports that patients' conditions worsened and led to joint replacements.
Following a U.S. Food and Drug Administration request, Pfizer isn't recruiting any new patients or giving the drug to patients already in 10 osteoarthritis trials.
According to Bloomberg:
"Tanezumab would generate an estimated $100 million in annual sales by the end of 2012, and $260 million by 2013 ... The drug was one of 500 projects the company had preserved in a pared-down development portfolio. Pfizer said in April 2009 that the drug as a treatment for the pain of osteoarthritis in the knee had moved into the third and final stage of testing usually needed for regulatory approval."