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Brentuximab for HL and ALCL

TOP - September 2011 Vol 4, No 6 published on September 21, 2011 in FDA Updates

The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris; Seattle Genetics) to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL).

With brentuximab, an antibody-drug conjugate, the antibody directs the drug to the target CD30. The agent is to be used in patients with HL whose disease has progressed after autologous stem-cell transplant or, for those who cannot receive a transplant, after 2 lines of chemotherapy. Brentuximab also may be used in patients with ALCL whose disease has progressed after 1 line of chemotherapy.

Approval was based on 1 clinical trial involving patients with HL. In the single-arm study, patients were treated solely with brentuximab. Of the study’s 102 patients, 73% achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.

Effectiveness in ALCL also was evaluated in 1 single-arm study. Of 58 patients receiving brentuximab for ALCL, 86% experienced either a complete or partial response and responded, on average, for 12.6 months.

The most common side effects reported include neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia. Pregnant women should be aware that brentuximab could cause harm to their unborn baby. Approval was granted under the FDA’s accelerated approval program. As such, the manufacturer is required to submit additional clinical information after approval to confirm the drug’s clinical benefit.

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Last modified: July 22, 2021