More PML problems from Adcetris


A pair of new cases involving progressive multifocal leukoencephalopathy (PML), a potentially fatal brain virus, have been reported to the Food & Drug Administration in patients who were receiving the recently approved Hodgkin lymphoma treatment Adcetris (previously known as SGN-35).

This brings the total known number of diagnoses in patients after receiving the antibody conjugate treatment to three.

This has prompted the FDA to order a black box warning to appear on the drug's label.

Adcetris is not the first recently approved drug to see some of its patients develop PML, including Tysabri, cladribine, and Rituxan. It is believed that PML is a result of the reactivation of latent infection with the JC virus.

Symptoms tend to resemble those of Alzheimer's: mood changes, behavioral changes, weakness, cognition problems, and problems with speaking, seeing and walking.

Source: FDA

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