FDA Plans to Strengthen Warning Label on Lymphoma Drug Adcetris
The FDA is to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to brain infection.
The US FDA plans to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to a rare, but deadly brain infection.
At the time of approval in August 2011, the regulator had seen one case of progressive multifocal leukoencephalopathy (PML) in a patient who had taken the drug, marketed by Seattle Genetics and Takeda Pharmaceutical. Since then, two more cases have been reported and the FDA is requiring a boxed warning - its strictest warning - to be placed on Adcetris' label.
The regulator has also warned that Adcetris should not be taken with cancer drug bleomycin due to increased risk of lung toxicity. Seattle Genetics must now conduct follow-up studies to confirm the safety of the treatment.
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