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).
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.
- 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.