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Medical Areas: Hematology | Oncology
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Adcetris (brentuximab vedotin)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Seattle Genetics
Approval Status: Approved August 2011
Treatment Area: Hodgkin lymphoma and anaplastic large cell lymphoma
Adcetris (brentuximab vedotin) is an antibody-drug conjugate comprised of an anti-CD30 antibody joined by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. Brentuximab vedotin is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect.
Adcetris is specifically approved for 1) Hodgkin lymphoma 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 and 2) systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.
Adcetris is supplied as a solution for intravenous infusion. The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every three weeks.
The FDA approval of Adcetris for Hodgkin lymphoma was based on an open-label, single-arm, multicenter trial.The trial enrolled 102 subjects with HL who relapsed after autologous stem cell transplant. The subjects were treated with 1.8 mg/kg of Adcetris intravenously over 30 minutes every three weeks. Efficacy was based on overall response rate (ORR = complete remission [CR] + partial remission [PR]) and duration of response. The ORR was 73% and the median duration of response was 6.7 months.
Systemic Anaplastic Large Cell Lymphoma
The FDA approval of Adcetris for systemic anaplastic large cell lymphoma was based on an open-label, single-arm, multicenter trial. The trial enrolled 58 subjects who had relapsed after prior therapy. The subjects received 1.8 mg/kg of Adcetris administered intravenously over 30 minutes every three weeks. Efficacy was based on overall response rate (ORR = complete remission [CR] + partial remission [PR]) and duration of response. The ORR was 86% and the median duration of response was 12.6 months.
Adverse events associated with the use of Adcetris may include, but are not limited to, the following:
- peripheral sensory neuropathy
- upper respiratory tract infection
Mechanism of Action
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.
Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. British Journal of Hematology 2009 Jul;146(2):171-9.
Bartlett NL, Younes A, Carabasi MH, Forero A, Rosenblatt JD, Leonard JP, Bernstein SH, Bociek RG, Lorenz JM, Hart BW, Barton J A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood 2008 Feb 15;111(4):1848-54
For additional information regarding Adcetris or Hodgkin lymphoma and anaplastic large cell lymphoma, please visit the Adcetris web page.