Adcetris (brentuximab vedotin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2011

Specific Treatments:

Hodgkin lymphoma and anaplastic large cell lymphoma

Therapeutic Areas

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General Information

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.

Clinical Results

FDA Approval
Hodgkin Lymphoma
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.

Side Effects

Adverse events associated with the use of Adcetris may include, but are not limited to, the following:

  • neutropenia
  • peripheral sensory neuropathy
  • fatigue
  • nausea
  • anemia
  • upper respiratory tract infection
  • diarrhea
  • pyrexia
  • rash
  • thrombocytopenia
  • cough
  • vomiting

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.

Literature References

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

Additional Information

For additional information regarding Adcetris or Hodgkin lymphoma and anaplastic large cell lymphoma, please visit the Adcetris web page.