The US Food and Drug Administration (FDA) approved brentuximab vedotin plus chemotherapy as a front-line therapy for patients with stage III or IV classical Hodgkin lymphoma (CHL), according to a press release.1

This marks the fifth FDA-approved indication for brentuximab vedotin and the first approval for front-line stage III or IV CHL in more than 4 decades.

The FDA based its approval based on findings from the open-label phase 3 ECHELON-1 study (ClinicalTrials.gov Identifier: NCT01712490), for which researchers randomly assigned 1334 patients with previously untreated stage III or IV CHL to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) or doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

After a median follow up of 24.6 months, patients in the A+AVD arm had a 2-year modified progression-free survival rate of 82.1% (95% CI, 78.8%-85.0%) vs 77.2% (95% CI, 73.7%-80.4%) among patients in the ABVD arm (hazard ratio for an event of progression, death, or modified progression [HR], 0.77; 95% CI, 0.60-0.98; P = .035).

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The safety profile of A+AVD was consistent with those previously reported for the individual components; the most frequently reported grade 3 to 4 adverse events in both study arms included neutropenia, febrile neutropenia, and anemia.  Other common adverse events in the A+AVD arm included peripheral neuropathy, vomiting, diarrhea, insomnia, bone pain, and dyspnea.

Reference

  1. Seattle Genetics announces FDA approval of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for adults with previously untreated stage III or IV classical Hodgkin lymphoma [news release]. Bothell, WA; Seattle Genetics; March 20, 2018. https://www.businesswire.com/news/home/20180320006276/en/Seattle-Genetics-Announces-FDA-Approval-ADCETRIS%C2%AE-Brentuximab. Accessed March 21, 2018.