US regulators have approved Seattle Genetics’ Adcetris in combination with chemotherapy for adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma.
The decision gives patients in this setting the first new treatment option in more than 40 years, the firm notes.
Clearance rides on the back of data from the Phase III ECHELON-1 clinical trial comparing Adcetris (brentuximab vedotin) plus AVD (adriamycin, vinblastine and dacarbazine) to ABVD (adriamycin, bleomycin, vinblastine and dacarbazine).
This showed that the combination resulted in a statistically significant improvement in modified progression-free survival (PFS) versus the control arm of ABVD as assessed by an Independent Review Facility, corresponding to a 23 percent reduction in the risk of progression, death or need for additional anticancer therapy in patients not in complete response (CR) after frontline treatment.
Results of the trial have also secured conversion of the drug’s accelerated approval to regular clearance as a treatment for systemic anaplastic large cell lymphoma (sALCL) in adults after failure of at least one multi-agent chemotherapy regimen.
Adcetris is already approved in the US across various indications for patients with classical Hodgkin lymphoma (cHL), sALCL or primary cutaneous anaplastic large cell lymphoma (pcALCL).