On March 20, 2018, the FDA granted Seattle Genetics, Inc. approval to market Adcetris® (Brentuximab Vedotin), in combination with chemotherapy, for the frontline treatment of patients with classical Hodgkin lymphoma (cHL) . The standard frontline regimen for patients with cHL is a four-drug chemotherapy regimen, ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine); however, up to 30% of patients are refractory to treatment or relapse after treatment . Brentuximab vedotin (BV) is a CD30-targeted antibody-drug conjugate that selectively delivers a cytotoxic agent to cHL cells, thus reducing systemic toxicity and enhancing anti-neoplastic activity . Brentuximab vedotin was previously approved as a salvage treatment and post-transplantation consolidation therapy for patients with cHL as well as for the second-line treatment of systemic and primary anaplastic large cell lymphoma and CD30expressing mycosis fungoides .
The most recent approval was based on the results of an open-label, multicenter, randomized phase 3 trial, ECHELON-1, comparing brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) to standard ABVD therapy for the frontline treatment of patients with stage III or IV cHL (NCT01712490) . A total of 664 patients received A+AVD while 670 patients received ABVD. Efficacy was based on a 2-year modified progression-free survival (the time to progression, death, or noncomplete response and use of subsequent anticancer therapy) rate which was 82.1% for A+AVD group and 77.2% for the ABVD group . Overall, patients receiving A+AVD experienced a 23% reduction in the risk of failure of the primary chemotherapy treatment. Additionally, treatment with A+AVD reduced the incidence of pulmonary toxicity supporting its use in this indication.
- ADCETRIS® (brentuximab vedotin) for injection, for intravenous use Drugs@FDA: FDA Approved Drug Products March 20, 2018 [cited 2018 April 26]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf.
- Connors, J.M., et al., Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma. N Engl J Med, 2018. 378(4): p. 331-344.
- Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma. ClinicalTrials.gov August 1, 2017 [cited 2018 April 27]; Available from: https://clinicaltrials.gov/ct2/show/NCT01712490.