The US Food and Drug Administration (FDA) has approved Seattle Genetics’ Adcetris (brentuximab vedotin) to be given in combination with chemotherapy to treat adults with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL).
Adcetris is an antibody drug conjugate comprised of an anti-CD30 monoclonal antibody linked by a protease-cleavable to a microtubule disrupting agent, monomethyl auristatin E.
The drug has already received four FDA approvals, including various indications of cHL, systemic anaplastic large cell lymphoma (sALCL) and primary cutaneous anaplastic large cell lymphoma.
Seattle Genetics president and CEO Clay Siegall said: “Currently, up to 30% of newly diagnosed advanced-stage cHL patients will experience disease progression after treatment with the current standard of care, representing a significant need for improved treatment options for these often younger patients.
“With today’s FDA approval, the physician and patient community have a new treatment option for previously untreated Stage III or IV Hodgkin lymphoma patients.”
FDA approval is based on data from a Phase III trial that compared Adcetris in combination with adriamycin, vinblastine and dacarbazine (AVD), with AVD in combination with bleomycin.
The primary endpoint of improved modified progression-free survival was met in patients administered with Adcetris and AVD combination. Similar positive findings were observed in overall survival and rate of complete response.
The safety profile of the combination therapy was found to be generally consistent with that of the regimen’s single-agent components.
Data from the trial converted the US accelerated approval of Adcetris from the treatment of adults with systemic anaplastic large cell lymphoma (sALCL) after the failure of at least one multi-agent chemotherapy regimen to regular approval.