FDA Update

On November 9, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adetris®, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Approval was based on a phase 3, randomized, open-label, multicenter clinical trial (Alcanza) of brentuximab vedotin in patients with MF or pcALCL who had previously received one prior systemic therapy and required systemic treatment. The trial randomized 131 patients (1:1) to receive either brentuximab vedotin or the physician’s choice of methotrexate or bexarotene.

Efficacy was established based on improvement in objective response rate lasting 4 months (ORR4), complete response (CR) rate, and progression-free survival (PFS) assessed by an independent review facility. ALCANZA demonstrated an improvement (p<0.001) in ORR4 in the brentuximab vedotin arm versus the physician’s choice arm, 56% (95% CI: 44%, 68%) versus 12% (95% CI 4%, 21%), respectively. CR rate was also superior (p=0.007) in the brentuximab vedotin arm versus the physician’s choice arm, 16% (95% CI: 8%, 27%) versus 2% (95%CI: 0, 8%). ALCANZA also demonstrated improvement in PFS with an estimated hazard ratio of 0.27 (95%CI 0.17, 0.43, p<0.001). The median PFS was 17 months in the brentuximab vedotin arm versus 4 months in the physician’s choice arm.

The most common adverse reactions occurring in less than 20% of patients receiving brentuximab vedotin were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. The most common adverse event leading to discontinuation was peripheral neuropathy.

The recommended dose of brentuximab vedotin is 1.8 mg/kg up to a maximum of 180 mg as an intravenous infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Full prescribing information is available.

FDA granted Breakthrough Therapy Designation, Orphan Designation, and priority review to brentuximab vedotin for this indication. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Follow the Oncology Center of Excellence on Twitter @FDAOncology.

Check out recent approvals at the OCE’s new podcast, Drug Information Soundcast in Clinical Oncology (DISCO).

In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

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