Posted from: Tuesday, April 03, 2018 - 03:50 PM - Present

New Indication for Adcetris

March 20, 2018 – The U.S. FDA has approved a new indication for Adcetris® (brentuximab vedotin), manufactured by Seattle Genetics. It is now approved for use in combination with chemotherapy to treat adult patients who have previously untreated stage III or stage IV classical Hodgkin lymphoma (cHL). Experts consider the new indication a meaningful development in the treatment options available for advanced Hodgkin lymphoma, which have remained largely unchanged for 40 years.

Approval for the new indication is based on a clinical trial in which Adcetris, when used with the chemotherapy combination ADV (Adriamycin, vinblastine, and dacarbazine), was found to have increased efficacy compared to the existing standard of care, the four-drug chemotherapy regimen known as ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine). The absence of bleomycin from the Adcetris and ADV regimen may also be of benefit to patients. Bleomycin has been shown to cause unpredictable and potentially fatal lung toxicity.

First approved in 2011, Adcetris has several additional indications for the treatment of cHCL, as well as other forms of lymphoma. According to a black box warning, patients treated with Adcetris may have an increased risk of contracting the John Cunningham virus, which can result in a rare but potentially fatal brain infection known as progressive multifocal leukoencephalopathy (PML).

Adcetris is currently being evaluated in more than 70 clinical trials, including studies to determine its application in treating mature T-cell lymphomas and, in combination with Opdivo (nivolumab), relapsed/refractory Hodgkin lymphoma.

 

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Last Updated Sunday, April 22, 2018 - 07:48 AM.