Please login to the form below

Not currently logged in
Email:
Password:

Pfizer withdraws cancer drug

Pfizer has withdrawn acute myeloid leukaemia drug, Mylotarg, from the US market after post-marketing data failed to demonstrate efficacy

Pfizer has withdrawn from the US market its acute myeloid leukaemia (AML) drug Mylotarg (gemtuzumab ozogamicin) after post-marketing data failed to demonstrate efficacy and showed that the drug's risks were higher than they appeared in earlier studies.

Mylotarg has been sold in the US for a decade, following clearance in May 2000 under the US Food and Drug Administration's (FDA) accelerated approval program, which allows the marketing of certain medications based on surrogate endpoints, or laboratory measurements used in place of actual clinical outcomes.

The drug was submitted to the FDA by Wyeth, which has since merged with Pfizer, and was cleared for marketing based on data from just 142 AML patients. The subjects were tested in studies that used the surrogate endpoint of response rate (the percentage of patients whose leukaemia decreased or disappeared in laboratory tests) rather than clinical survival data.

Companies must conduct post-marketing studies for drugs that receive accelerated approval, with the understanding that if the studies are not carried out or are not successful, the drug will be pulled from the market.

Wyeth began a trial in 2004 to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in survival time, and halted the study early when no improvement in clinical benefit was observed and more deaths occurred in the Mylotarg group than in the group receiving chemotherapy alone.

Post-marketing data also has shown that the rate of veno-occulusive disease, a serious liver condition that was linked to the drug in the premarket trials, is higher than was thought.

The withdrawal was conducted voluntarily by Pfizer following a request from the FDA. Pfizer said it is also in discussions about the drug with regulatory bodies outside the US.

22nd June 2010

Share

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Havas Lynx Group

We are the Havas Lynx Group. Devoted to fresh thinking. Changing the way the world does healthcare communications for the...

Latest intelligence

Lifting the fog to help Clinical Labs navigate IVDR 2022
In Vitro Diagnostic Regulation (IVDR 2022) was on the horizon: a new regulatory basis for laboratories to adhere to regarding their diagnostic equipment and tests. BD wanted to let their...
Empowering adolescents to manage emotional and mental health issues
1 in 10 UK children suffer with a mental health issue and alarmingly as many as 70% of these don’t receive the proper support they need. That’s why The Anna...
Reframing rare to increase earlier diagnosis of Gaucher Disease
Sanofi Genzyme wanted to reach haematologists; the specialist physicians most likely to encounter patients with Gaucher Disease prior to diagnosis. The problem? Gaucher Disease is considered very rare and its...