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# FDA Approves Expanded Adcetris Indication
- URL: https://www.fdaweb.com/fda-approves-expanded-adcetris-indication/
- Published: 2018-03-21T12:00:00.000Z
- Updated: 2026-09-14T23:54:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141034

FDA has approved an expanded indication for Seattle Genetics’ Adcetris (brentuximab vedotin) to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy. An FDA [media statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm?ref=fdaweb.com) says Adcetris combines an antibody and a drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris previously was approved to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic analplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment.

The statement says approval of the expanded indication was based on a clinical trial comparing Adcetris plus chemotherapy to a chemotherapy-only regimen common for cHL treatment. In the trial of 1,334 patients, those who received Adcetris with chemotherapy were 23% less likely to experience progression, death, or initiation of new therapy compared with those receiving chemotherapy alone,

Common side effects of Adcetris are said to include neutropenia and anemia, peripheral neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia. The drug carries a Boxed Warning highlighting the risk of John Cunningham virus infection resulting in progressive multifocal leukoencephalopathy.

The Adcetris application had been given priority review and breakthrough therapy designations by FDA.