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PMID
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Title Adcetris (brentuximab vedotin) FDA Drug Label
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125388
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Brentuximab vedotin Brentuximab vedotin 4 10
Drug Name Trade Name Synonyms Drug Classes Drug Description
Brentuximab vedotin Adcetris SGN-35 Adcetris (brentuximab vedotin) is an antibody-drug conjugate comprised of a monoclonal antibody targeting CD30 linked to the tubulin-binding drug MMAE, which binds CD30-expressing cells and disrupts microtubule polymerization, potentially resulting in decreased tumor growth (PMID: 22684302). Adcetris (brentuximab vedotin) is FDA approved for Hodgkin lymphoma, anaplastic large cell lymphoma, CD30-expressing mycosis fungoides, and in combination with chemotherapy in other CD30-expressing peripheral T-cell lymphomas (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Hodgkin's lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase III trial (AETHERA) that supported FDA approval, Adcetris (brentuximab vedotin) treatment as consolidation therapy after autologous stem-cell transplantation resulted in significantly improved progression-free survival compared to placebo (42.9 vs 24.1 months, HR=0.57, p=0.0013) in patients with classical Hodgkin's lymphoma at risk for relapse or progression after transplantation (PMID: 25796459; NCT01100502). detail... 25796459
Unknown unknown anaplastic large cell lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase II trial (SGN-35) that supported FDA approval, Adcetris (brentuximab vedotin) treatment resulted in complete remission in 57% (33/58), partial remission in 29% (17/58) of patients with relapsed or refractory systemic anaplastic large cell lymphoma (PMID: 22614995; NCT00866047). 22614995 detail...
Unknown unknown Hodgkin's lymphoma not applicable Brentuximab vedotin FDA approved Actionable In a Phase II trial that supported FDA approval, Adcetris (brentuximab vedotin) treatment resulted in an objective response rate of 73% (72/102, 33 complete response, 38 partial response) in patients with relapsed or refractory classical Hodgkin's lymphoma following autologous stem cell transplantation (PMID: 25533035; NCT00848926). detail... 25533035
Unknown unknown Hodgkin's lymphoma not applicable Brentuximab vedotin + Dacarbazine + Doxorubicin + Vinblastine FDA approved Actionable In a Phase III trial (ECHELON-1) that supported FDA approval, Adcetris (brentuximab vedotin) in combination with Deticene (dacarbazine), Adriamycin (doxorubicin), and Velban (vinblastine) improved modified progression-free survival rate (82.1% vs 77.2%, HR=0.77, p=0.04) compared to the combination of Adriamycin (doxorubicin), Blenoxane (Bleomycin), Velban (vinblastine) and Deticene (dacarbazine) in patients with untreated stage III or IV classical Hodgkin's lymphoma (PMID: 29224502; NCT01712490). 29224502 detail...