Micrograph showing HL
The US Food and Drug Administration (FDA) has granted accelerated approval for brentuximab vedotin (Adcetris) to treat patients with Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL).
The drug can now be used to treat HL patients after the failure of autologous stem cell transplant (ASCT) or, in patients who are not ASCT candidates, after they fail at least 2 prior multiagent chemotherapy regimens.
Brentuximab vedotin can also be used to treat patients with sALCL after the failure of at least 1 prior multiagent chemotherapy regimen.
About accelerated approval
The FDA instituted its accelerated approval program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The approval is based on a surrogate endpoint that is not a measure of clinical benefit.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If these confirmatory trials suggest the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. If the confirmatory trial does not show a clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Brentuximab vedotin in HL
Accelerated approval for the HL indication was based on a single-arm, multicenter trial to evaluate the objective response rate of brentuximab vedotin as a single agent. The 102 patients enrolled in the trial had CD30-positive HL that relapsed following ASCT.
Brentuximab vedotin prompted an overall response rate in these patients of 73%, with a median response duration of 6.7 months.
Thirty-two percent of patients achieved a complete remission, with a median duration of 20.5 months. Forty percent of patients achieved a partial remission, with a median duration of 3.5 months.
Brentuximab vedotin in sALCL
Accelerated approval for the treatment of sALCL was based on a single-arm, multicenter trial as well. The study included 58 patients with CD30-positive sALCL who had previously received frontline, multiagent chemotherapy treatment.
The primary efficacy endpoint of overall response rate was achieved in 86% of sALCL patients, with a median duration of 12.6 months.
Fifty-seven percent of patients achieved a complete remission, with a median duration of 13.2 months. Twenty-nine percent of patients achieved a partial response, with a median duration of 2.1 months.
The recommended dose and schedule for both indications is 1.8 mg/kg given intravenously over 30 minutes every 3 weeks. Treatment may last a total of 16 cycles, or until disease progresses or toxicity becomes unacceptable.
The agent, manufactured by Seattle Genetics under the trade name Adcetris, is the first new treatment for HL to be approved by the FDA since 1977 and the first to be indicated for sALCL.
