Seattle Genetics asserted EC’s extension of marketing authorization for ADCETRIS
Seattle Genetics confirmed that its collaborator, Takeda Pharmaceutical Company Limited has asserted the fact that European Commission has extended the current conditional marketing authorization for ADCETRIS to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The marketing authorization for ADCETRIS is valid in 28 countries of the European Union (EU), Norway, Liechtenstein and Iceland. It is based on positive results from a phase 3 trial called ALCANZA that were presented at the 58th American Society of Hematology (ASH) annual meeting in December 2016, published online in the Lancet in June 2017, and recently updated in a poster presentation at the 59th ASH annual meeting in December 2017. The trial achieved its primary endpoint with the ADCETRIS treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months versus the control arm as evaluated by an independent review facility. The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm (p-value <0.001). The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in skin symptom burden as measured by the Skindex-29 questionnaire, were all highly statistically significant in favor of the ADCETRIS arm.
Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics said “The approval of ADCETRIS for use in the European Union in CD30-positive CTCL patients represents a meaningful advance for patients with CTCL. We are pleased that our partner Takeda is able to make this therapeutic option available to patients in Europe. Since ADCETRIS was first approved by the FDA in 2011, Seattle Genetics and Takeda have made significant progress in our goal to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas, and we are working together on our next milestone of securing FDA approval and European Union marketing authorization for ADCETRIS’ use as a treatment for frontline advanced Hodgkin lymphoma.”