ADCETRIS™ (generic name: brentuximab vedotin) is a new drug for treating Hodgkin Lymphoma (HL). On March 26, 2012, the makers of ADCETRIS announced that their clinical trial of ADCETRIS was quite successful.
Three-quarters of the 100-plus HL patients treated with ADCETRIS showed lasting positive responses to the drug. However, the press release from Seattle Genetics, Inc., ADCETRIS’s developer and manufacturer, also notes that the latest Warnings and Precautions for ADCETRIS include the following:
“Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death [emphasis ours] has been reported in ADCETRIS-treated patients.
Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities.
Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.”
Moreover, the Boxed Warning for ADCETRIS states that ” Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.”
The results of this latest clinical trial, an open-label, phase II examination, have served as the basis for an accelerated FDA approval of ADCETRIS in August 2011. However, several patients who were treated with ADCETRIS have developed PML, which is a life-threatening complication. As is often the case with newly developed drugs, an accelerated approval is controversial, and the FDA has ended up later “revising” its approval for new drugs when complications and side effects accumulate.
In fact, in January 2012, after several new cases of PML in ADCETRIS-treated patients were reported, the FDA required that the ADCETRIS warnings be updated to warn of this risk.
ADCETRIS is also FDA-approved for the treatment of anaplastic large-cell lymphoma (ALCL). When a person with HL or ALCL is treated with ADCETRIS, he or she should be aware of the symptoms of PML, which include:
- loss of cognition/ability to think clearly
- physical weakness
- sudden problems with vision, walking, or speech
- unexplained changes in mood or behavior
If you have concerns related to ADCETRIS or another drug related to PML, talk with a knowledgeable PML lawyer by contacting us today.