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The pharmaceutical company Pfizer withdraws the cancer drug "Mylotarg" from the market after ten years. Did people have to die because the drug was not tested enough?
(June 22, 2010) The US pharmaceutical company Pfizer has withdrawn the cancer drug "Mylotarg" from the market.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 shown that the blood cancer drug has no benefit for patients. Studies have raised concerns about the safety of the drug. The medicine was given to patients with acute myeloid leukemia (AML). The patients could not receive any other chemotherapy with the clinical picture. Earlier, the US FDA had pointed out that the drug could have caused a higher death rate without recognizing medical benefits for the patients.
The company announced on Monday that it regretted "that the study has not confirmed the clinical effects of Mylotarg". The drug approval agency FDA had previously asked the company to withdraw the drug "Mylotarg" from the US market. But how could the drug be approved on the drug market at all? Mylotarg was released in 2000 as part of an accelerated approval program. The program is designed to allow medication to be approved more quickly if there are insufficient therapies for certain diseases. However, a so-called "post-marketing study" had shown that the drug did not benefit patients. It was also demonstrated that the number of deaths in the first months of administration was significantly higher than in the comparison group with ineffective placebos.
The European Union had already refused to approve the drug in January 2008 and questioned the effectiveness of the drug. However, Mylotarg is also sold in nine other countries. The drug had quarterly sales of around nine million euros. The pharmaceutical company "Pfizer" acquired the rights of the drug in October 2009 with the takeover of the then pharmaceutical company "Wyeth". (sb)