Pfizer withdraws AML monoclonal antibody Mylotarg from US market

Pharmaceutical giant Pfizer is withdrawing the monoclonal antibody Mylotarg (gemtuzumab ozogamicin) from the US market, the company's treatment for patients with Acute Myeloid Leukemia (AML), ten years after the drug was approved by the FDA under its accelerated approval program.

Pfizer does so at the behest of the FDA following concerns regarding the safety and efficacy of Mylotarg. It was initially approved for the treatment of AML patients 60 and older whose AML was recurrent and who were not considered good candidates for chemotherapy.

Said Dr Richard Pazdur, head of the FDA's Office of Oncology Drug Products:

"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."

Source: Pfizer press release