Second Adcetris patient reported to develop fatal brain virus

Submitted by Ross Bonander Thu 12/01/2011

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Word has come down of a second patient who was receiving Seattle Genetics' flagship oncology product Adcetris (brentuximab vedotin) who has developed the often fatal brain virus progressive multifocal leukoencephalopathy (PML). The company has reported the case to the FDA, but has not released any information on the health or welfare of the patient.

The first patient who developed PML while receiving Adcetris did so during the clinical trial phase and is deceased, but this was hardly a well-kept secret. Rather, Adcetris' prescribing information includes this information.

Adcetris, long known as SGN-35, was approved by the FDA in the late summer of 2011 for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma.

Progressive multifocal leukoencephalopathy (PML) has a lengthy association with the development of targeted treatments, as it has been an issue among patients taking the monoclonal antibody Rituxan, and was enough of an issue to cause natalizumab (Tysabri) to be removed from the market temporarily.

Source: Xconomy

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