Pfizer has said it plans to withdraw acute myeloid leukaemia drug Mylotarg from the US market, after a clinical study indicated it had few benefits for patients.
The Food and Drug Administration (FDA) requested the withdrawal after the study raised concerns about Mylotarg’s safety and the drug failed to show clinical benefits.
The regulator said the post-approval clinical trial also found that a greater number of deaths occurred in patients who received Mylotarg compared to chemotherapy alone.
Patients currently taking Mylotarg may continue their course of therapy in consultation with their physician, but the drug will not be commercially available to new patients.
Mylotarg was approved in 2000 under the FDA’s accelerated approval process.
The initial approval was based on the surrogate endpoint of response rate observed in 142 patients with acute myeloid leukaemia across three clinical trials.