Seattle Genetics and Takeda Pharmaceutical have received extended marketing authorisation from the European Commission (EC) for ADCETRIS (brentuximab vedotin) to treat CD30-positive cutaneous T-cell lymphoma (CTCL) in adults following at least one previous systemic therapy.
ADCETRIS is currently being studied in more than 70 clinical trials and formulated as an antibody-drug conjugate (ADC) to target CD30 expressed on the surface of several types of lymphoma cells.
The EC marketing authorisation covers the European Union (EU), Norway, Liechtenstein and Iceland.
Seattle Genetics president and CEO Clay Siegall said: “The approval of ADCETRIS for use in the European Union in CD30-positive CTCL patients represents a meaningful advance for patients with CTCL.
“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 EU marketing authorisation for ADCETRIS’ use as a treatment for frontline advanced Hodgkin lymphoma.”
The EC reviewed findings from the Phase III ALCANZA trial that is reported to have met the primary endpoint with statistically significant improvement in the objective response rate using ADCETRIS.
Compared to 12.5% in the control arm, the objective response lasting at least four months (ORR4) was found to be 56.3% in the ADCETRIS arm.
The trial also demonstrated statistically significant key secondary endpoints such as complete response rate and progression-free survival with ADCETRIS.