Brentuximab Vedotin Received FDA Approval for Stage 3-4 Hodgkin Lymphoma Line 1 Treatment

On 20 March 2018, the United States Food and Drug Administration, FDA, for use with chemotherapy in untreated adult stage III or IV classical Hodgkin lymphoma (cHL), approved brentuximab vedotin(brand name Adcetris).

Approval was based on a randomized, open-label, two-arm, multicenter study, ECHELON-1, involving 1.334 patients, a clinical study . Patients were randomized, in each 28-day cycle on days 1 and 15 for up to 6 cycles, to brentuximab vedotin with doxorubicin, vinblastine and dacarbazine (Adcetris + AVD), or bleomycin with AVD (ABVD).

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Efficacy was determined in patients without complete response after initial treatment using an additional time from starting anticancer treatment until death or disease progression as the definition of modified progression-free survival . Median follow-up was 24.6 months, and estimated median modified progression-free survival was not reached in either arm. Brentuximab vedotin + AVD had 117 events (18%), versus 146 (22%) with ABVD; the brentuximab arm's risk of a modified progression-free survival event fell by 23%. At analysis, interim overall survival did not differ significantly.

Across all brentuximab vedotin studies, in at least 20% of patients the most common side effects were reduced white blood cells (leukopenia), anemia, nerve damage in arms and legs (peripheral neuropathy), nausea, fatigue, constipation, diarrhea, vomiting and fever. Primary G-CSF prophylaxis (white-cell-raising injections) is recommended with brentuximab vedotin and chemotherapy for initial treatment of stage III or IV classical Hodgkin lymphoma.

In untreated stage III or IV classical Hodgkin lymphoma, the recommended dose with chemotherapy of brentuximab vedotin is every 2 weeks for up to 12 cycles, by intravenous infusion, at 1.2 mg/kg (maximum 120 mg).

Adcetris first received FDA approval in 2011 for recurrent or treatment-resistant lymphoma.