FDA Approves Front-Line Brentuximab Vedotin Plus Chemotherapy for Hodgkin Lymphoma

Share this content:
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.
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 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.

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.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs