Adcetris (Brentuximab Vedotin) - Summary

ADCETRIS SUMMARY

ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent MMAE, and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10.

ADCETRIS is indicated for the following:

Hodgkin Lymphoma

ADCETRIS (brentuximab vedotin) is indicated for treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14.1 ) ].  An improvement in patient-reported outcomes or survival has not been established.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Systemic Anaplastic Large Cell Lymphoma

ADCETRIS is indicated for treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14.2 ) ].  An improvement in patient-reported outcomes or survival has not been established.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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NEWS HIGHLIGHTS

Published Studies Related to Adcetris (Brentuximab Vedotin)

Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. [2015]
stem-cell transplantation... INTERPRETATION: Early consolidation with brentuximab vedotin after autologous

Brentuximab vedotin: treatment role for relapsed refractory systemic anaplastic large-cell lymphoma. [2013]
The identification of CD30 has been known since 1985.Brentuximab vedotin is currently being evaluated to be used in conjunction with other chemotherapy regimens, including in frontline therapies to induce potentially higher complete remission rate than chemotherapy alone and thus achieve potentially higher progression-free survival rates that might translate ultimately to improve overall survival.

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Clinical Trials Related to Adcetris (Brentuximab Vedotin)

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies [Completed]
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL) [Recruiting]
This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.

Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML) [Active, not recruiting]
This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2. The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the combination of brentuximab vedotin and azacytidine can help to control AML.

Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient [Recruiting]
Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged > than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients. The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients. Thus, the aim of this study will be to assess safety and efficacy of the above association.

Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas [Not yet recruiting]
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.

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