The Food and Drug Administration has granted priority review designation to Adcetris (brentuximab vedotin) for the consolidation treatment of patients with Hodgkin lymphoma who are at high risk of relapse or progression immediately following an autologous stem cell transplant.
Adcetris, made by Seattle Genetics, is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL), as well as other lymphoma subtypes.
Adcetris is currently approved for the treatment of relapsed Hodgkin lymphoma and ALCL, but it is not currently approved for consolidation therapy for patients with Hodgkin lymphoma immediately after stem cell transplant (OT 9/25/11 issue).
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for Adcetris for this indication is August 18.
Adcetris was evaluated in the double-blind, placebo-controlled AETHERA Phase III clinical trial of 329 patients with unfavorable-risk relapsed or primary refractory classic Hodgkin lymphoma who had undergone autologous stem-cell transplant (OT 1/10/15 issue).
The patients were randomized to receive 16 cycles of Adcetris or placebo injection every three weeks, starting 30 to 45 days after transplant. Median progression-free survival was 43 months for patients who received Adcetris compared with 24 months for patients who received the placebo. The two-year progression-free survival rate was 63 percent for the patients who received Adcetris compared with 51 percent for the patients who received the placebo.
The benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy, and patients who relapsed after 12 months with extranodal disease. The most common adverse events for patients who received Adcetris reported in the trial were peripheral sensory neuropathy, neutropenia, upper respiratory tract infection, fatigue, and peripheral motor neuropathy.