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Adcetris Approved for Primary Cutaneous ALCL

FDA news release; 2017 Nov 9

Publish date:: November 15, 2017

The FDA has approved Adcetris (brentuximab vedotin) for the treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF).

Indications: Adcetris is a CD30-directed antibody-drug conjugate indicated for treatment of adult patients with pcALCL or CD30 expressing MF who have received prior systemic therapy.

Dosage and administration: Administer only as an intravenous infusion over 30 minutes every 3 weeks. The recommended dose is 1.8 mg/kg up to a maximum of 180 mg. Reduce dose in patients with mild hepatic impairment.

Efficacy and safety: Approval is based on study results showing improvement in objective response rate, complete response rate, and progression-free survival assessed by an independent review facility.

Side effects/risks: The most common adverse reactions are peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.

Citation:

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma. [news release]. Silver Spring, MD: FDA. November 9, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm584543.htm?utm_campaign=Oncology%2011%2F9&utm_medium=email&utm_source=Eloqua&elqTrackId=06d11c937bec44c79cd3d453daecb608&elq=ed04a714845d4eaeafb58482063182e6&elqaid=1283&elqat=1&elqCampaignId=76. Accessed November 13, 2017.

Brentuximab vedotin [package insert]. Bothell, WA: Seattle Genetics, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf. Accessed November 13, 2017.

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