FDA Approves Rare Skin Cancer Treatment

fda alertThe US Food and Drug Administration (FDA) has expanded approval of brentuximab vedotin (Adcetris, Seattle Genetics). The antibody-drug conjugate targeting CD30 now is approved to treat adults with primary cutaneous anaplastic large cell lymphoma (ALCL).ALCL or CD30-expressing mycosis fungoides who have received prior systemic therapy. 

The approval was based on a phase 3 trial and 2 phase 2 trials. In the phase 3 trial, brentuximab vedotin demonstrated superior 4-month objective response rate, complete response rate, and progression-free survival compared with physician’s choice of methotrexate or bexarotene. The objective response lasting 4 months was 56.3% (95% CI: 44.1, 68.4) in the brentuximab vedotin study compared to 12.5% (95% CI: 4.4, 20.6) in the control (P<0.001). The safety profile was generally consistent with the existing prescribing information.

The most commonly reported adverse reactions (≥ 20 percent) were anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia.

The FDA had previously granted priority review to brentuximab vedotin for the treatment of cutaneous T-cell lymphoma in August. This is the fourth FDA-approved indication for Brentuximab vedotin, which also has: (1) regular approval for treatment of classical Hodgkin lymphoma (cHL) patients who fail autologous hematopoietic stem cell transplantation (auto-HSCT) or who fail at least two prior multi-agent chemotherapy regimens and are not auto-HSCT candidates, (2) regular approval for the treatment of patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for treatment of systemic anaplastic large cell lymphoma (sALCL) patients who fail at least one prior multi-agent chemotherapy regimen.

Zachary Bessette & Julie Gould