The European Commission has approved Adcetris (brentuximab vedotin) for the treatment of adults with CD30-positive Hodgkin’s lymphoma at increased risk of relapse or progression after autologous stem cell transplant (ASCT), according to Seattle Genetics, which announced that its collaborator, Takeda Pharmaceutical, will be marketing Adcetris.
“With the European Commission approval, Adcetris becomes the first and only consolidation treatment option available in both the United States and European Union for high risk classical Hodgkin’s lymphoma patients to preserve their remission post-transplant,” Clay Siegall, Ph.D., president and CEO of Seattle Genetics, said in a press release.
“This continues to support our goal to establish Adcetris as the global foundation of therapy for classical Hodgkin’s lymphoma and CD30-expressing lymphomas and provides a meaningful advance for cancer patients,” he said.
The approval was based on the AETHERA Phase 3 study designed to evaluate the efficacy of up to 16 cycles of Adcetris therapy administered following ASCT, compared to a placebo. Two years post-ASCT, patients on Adcetris showed a progression-free survival (PFS) of 65 percent, compared to the 45 percent in the placebo group.
This approval follows approval by the U.S. FDA in August 2015 for a similar application, and is the third indication for Adcetris in the E.U.
In October 2012, Adcetris was approved by the European Commission for two other indications. The first was for treatment of CD30-positive Hodgkin’s lymphoma patients who relapsed or are refractory to ASCT, or following at least two prior therapies when multi-agent chemotherapy or ASCT is not a treatment option.
The second was for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
Adcetris is now being evaluated in more than 70 clinical trials. Those include the Phase 3 ALCANZA clinical trial evaluating Adcetris versus physician’s choice (methotrexate or bexarotene) in CD30-positive cutaneous T-cell lymphoma, and the ECHELON-1 and ECHELON-2 trials, comparing Adcetris with AVD (doxorubicin, vinblastine, and dacarbazine) or CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone) in classical Hodgkin’s lymphoma or CD30-positive mature T-cell lymphomas, respectively.
Adcetris is an antibody-drug conjugate. It combines an antibody against CD30, a molecule that is found at the surface of Hodgkin’s lymphoma cells, that is linked to a drug that disrupts microtubules, called monomethyl auristatin E (MMAE), thereby inhibiting cancer cell progression.