'Black box' warning for Seattle Genetics' Adcetris

16 January 2012

US biotech Seattle Genetics (Nasdaq: SGEN) saw its shares fall 5.2% to $17.49 on Friday, after the company announced updates to the US prescribing information (PI) for Adcetris (brentuximab vedotin), the first new treatment for Hodgkin lymphoma in 34 years. The revised PI will include the following updated information:

• A boxed warning related to the risk that JC (John Cunningham) virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving Adcetris.

• A discussion in the PML warning and precaution provision regarding other possible contributing factors to PML such as other prior therapies and underlying disease, symptoms to be aware of and suggested methodologies for diagnosis of PML.

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