Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Adcetris Approved for Primary Cutaneous ALCL
FDA news release; 2017 Nov 9
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.
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.