Pharmaceutical company withdraws cancer drug

Pharmaceutical company Pfizer withdraws the cancer drug "Mylotarg" from the market after ten years. People had to die because the drug was not adequately tested?

(22.06.2010) The US pharmaceutical company Pfizer has withdrawn the cancer drug "Mylotarg" from the market. After a good ten years, a new study would have revealed that the blood cancer drug has no benefit for the patients. For example, studies have raised concerns about the safety of the drug. The drug has been given to patients because of acute myeloid leukemia (AML). The patients could not receive any other chemotherapy with the condition. Earlier, the US Food and Drug Administration (FDA) had pointed out that using the drug would result in higher death rates without any medical benefit to patients.

On Monday, the company announced it was "regretting that the study did not confirm the clinical effects of Mylotarg." The drug regulatory agency FDA had previously asked the company to withdraw the drug "Mylotarg" from the US market. But how could the drug even be approved on the drug market? Mylotarg was released in 2000 as part of an accelerated approval program. The program is designed to allow drugs faster, if there are no adequate therapies for certain diseases. However, a so-called "post-marketing study" had shown that the drug causes no benefit for the patients. In addition, it was shown that the number of deaths in the first months of administration was significantly higher than in the comparison group with non-effective placebos.

Already in January 2008, the European Union refused approval of the drug and doubted the effectiveness of the preparation. Mylotarg is still distributed in nine other countries. The drug posted quarterly sales of around nine million euros. The pharmaceutical company "Pfizer" had acquired the rights of the drug in October 2009 with the acquisition of the then pharmaceutical company "Wyeth". (Sb)