Seattle Genetics announced that the Food and Drug Administration (FDA) has approved Adcetris (brentuximab vedotin) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
The FDA approval was supported by data from ALCANZA, a Phase 3 trial (n=128), and two Phase 2 investigator-sponsored trials (n=73). In ALCANZA, Adcetris monotherapy given every 3 weeks was compared to physician’s choice of representative standard of care options (methotrexate or bexarotene). The primary endpoint was achieved with Adcetris-treated patients showing a highly statistically significant improvement in objective response rate lasting ≥4 months (ORR4) vs. the control group (56.3% vs. 12.5%; P<0.001).
Major secondary endpoints, such as ORR (67.2% vs. 20.3%), complete response rate (15.6% vs. 1.6%; P=0.0066), and progression-free survival (16.7 months vs. 3.5 months; hazard ratio [HR] 0.270, 95% CI: 0.169, 0.430; P<0.001) were all highly statistically significant favoring the Adcetris group over the control group.
Anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia were the most commonly reported adverse reactions, occurring in ≥20% of patients.
Adcetris, a CD30-directed antibody-drug conjugate, is already indicated for the treatment of classical Hodgkin lymphoma (cHL) patients who fail autologous hematopoietic stem cell transplantation (auto-HSCT) or who fail ≥2 prior multi-agent chemotherapy regimens and are not auto-HSCT candidates and for the treatment of patients with cHL at high risk of relapse or progression as post-auto-HSCT consolidation. The drug was also granted accelerated approval for the treatment of systemic anaplastic large cell lymphoma (sALCL) patients who fail at least one prior multi-agent chemotherapy regimen.
Adcetris is available as a 50mg/vial lyophilized powder for intravenous (IV) infusion in single-use vials.
For more information call (855) 473-2436 or visit Adcetris.com.