Quoted from http://online.wsj.com/article/SB10001424052748704895204575321210108285270.html
Pfizer to Withdraw a Cancer Drug Mylotarg
- JUNE 22, 2010
By JENNIFER CORBETT DOOREN
WASHINGTON—The Food and Drug Administration said Monday Pfizer Inc. is withdrawing its cancer drug Mylotarg from the U.S. market after a clinical study showed the drug wasn't effective and had more safety problems.
Mylotarg, marketed by Wyeth until Pfizer bought the company last year, was approved in 2000 as part of FDA's accelerated-approval program. The drug was approved for patients age 60 and older with a type of acute myeloid leukemia, a bone-marrow cancer. About 2,500 patients in the U.S. are treated with the product annually. Pfizer said it would voluntarily withdraw the new-drug application for Mylotarg effective Oct. 15, 2010, which will allow patients currently being treated with the product to stay on treatment if necessary. The FDA said Mylotarg shouldn't be offered to new patients.
The FDA's accelerated-approval program allows drugs to be approved on less clinical data than typically required for a normal approval and is used for patients considered to have unmet medical needs.
However, companies that have drugs approved under the agency's accelerated-approval mechanism need to continue studying them and apply for regular approval. The FDA can require a drug given accelerated approval be removed from the market if additional studies fail to show the drug has benefits.
FDA officials said Mylotarg is the first drug approved under the accelerated approval mechanism that will be removed from the market. In 2005, the FDA restricted the use of AstraZeneca PLC'S lung cancer drug Iressa to a certain group of patients after a clinical study showed it didn't prolong survival.
In Mylotarg's case, studies conducted at the time of approval showed up to 30% of patients responded to the drug, which means the number of leukemia cells were reduced or eliminated. The FDA required Wyeth to conduct a follow-up study involving Mylotarg to see if the product allowed patients to live longer.
The study, which involved 627 patients, started in 2004 and was stopped early in 2009 after an interim analysis showed patients being treated with Mylotarg didn't appear to receive any additional clinical benefit and had a higher death rate. All patients in the study were given standard chemotherapy drugs while some patients were also treated with Mylotarg.
The FDA also said at the time of its approval that Mylotarg was associated with a serious liver condition called veno-occlusive disease, the rate of which has increased in the postmarket setting.