New Indication for Adcetris
November 9, 2017 – The U.S. FDA has approved a new indication for Adcetris® (brentuximab vedotin), manufactured by Seattle Genetics, to treat adult patients with cutaneous T-Cell Lymphoma (CTCL) who have been treated previously for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF). Adcetris is an antibody-drug conjugate, and works by binding to specific markers on cancer cells and delivering an anticancer agent.
Recommended dosing is based on weight, at 1.8mg/kg, and should be given once every three weeks. Adcetris is delivered by intravenous (IV) infusion. Individual doses should not exceed 180mg, and patients should receive no more than 16 total doses over the course of treatment. In a clinical study, 67.2% of patients who received Adcetris experienced an improvement in objective response rates. Progression-free survival rates were longer (16.7 months) for patients treated with Adcetris when compared to those who received the standard care of either methotrexate or bexarotene (3.5 months).
Adcetris holds previous FDA approvals for treatment of certain types of ALCL Hodgkin’s lymphomas. It is currently being studied as a potential treatment for various other forms of cancer, either as a monotherapy or in conjunction with additional oncology drugs. A black box warning cautions patients that Adcetris has been associated with the development of progressive multifocal leukoencephalopathy (PML), a rare demyelinating viral disease of the brain that can often be fatal or lead to severe disability.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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