Pfizer withdraws blood cancer drug in US
pharmafile | June 22, 2010 | News story | Sales and Marketing | AML, Mylotarg, Pfizer, blood cancer
The US regulatory body has withdrawn Pfizer’s leukaemia drug Mylotarg after it was linked to a number of deaths, and showed no clinical benefit, in post-marketing trials.
A post-marketing clinical trial was originally begun by Wyeth (now Pfizer) in 2004 to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in survival to acute myeloid leukaemia (AML) patients.
The trial was stopped early when a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
Dr Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer oncology business unit, said: “We are disappointed that the study did not confirm the clinical benefit of Mylotarg.
“Our primary concern is for patients who suffer from AML, which remains a very serious and difficult-to-treat disease with limited treatment options.”
AML is a fast growing form of blood cancer, and Mylotarg was indicated for patients aged 60 years and older with recurrent AML who were not considered candidates for other chemotherapy.
At initial approval, Mylotarg was associated with veno-occlusive disease, a potentially fatal liver condition, and the rate of this increased in the post-market setting.
Richard Pazdur, director of the office of oncology drug products, part of the FDA’s Center for Drug Evaluation and Research, said: “Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer.
“However, a confirmatory clinical trial and years of post-marketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
Mylotarg will no longer be commercially available to new patients. Following the withdrawal, any future use of Mylotarg in the US will require submission of an investigational new drug application to the FDA.
Ben Adams
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