Seattle Genetics announced that it has updated the prescribing information for Adcetris (brentuximab vedotin injection) to include a boxed warning, a new contraindication, and discussion of progressive multifocal leukoencephalopathy in the warnings. The revised labeling now includes:

  • A boxed warning related to the risk that JC 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
  • A contraindication warning of the concomitant use of Adcetris and bleomycin due to pulmonary toxicity

Adcetris is a CD30-directed antibody-drug conjugate indicated for the treatment of Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates. Adcetris is also indicated for the treatment of systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

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