The European Commission has extended conditional marketing authorisation for Takeda’s Adcetris to include the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL) following one prior systemic therapy.
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) directed at CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL, a subtype of non-Hodgkin lymphoma that primarily involves the skin.
“There are few approved CTCL treatment options with only limited efficacy, creating a significant unmet need for these patients,” said Julia Scarisbrick, Department of Dermatology, University Hospital Birmingham, Birmingham, UK.
“The approval of Adcetris in this setting brings a much needed, effective treatment option to patients living with CTCL and I am looking forward to be able to offer this treatment to CD30-positive patients who have received one prior systemic therapy.”
According to data from the Phase III ALCANZA trial, Adcetris provided “a highly statistically significant improvement” in the overall response rate lasting at least four months (ORR4) versus the control arm of methotrexate or bexarotene as assessed by an independent review facility, with figures showing 56.3 percent versus 12.5 percent, respectively.
Takeda noted that complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, were all highly statistically significant in favor of the Adcetris arm.
“The clinical data that supported this approval are exceptionally strong. We are proud to be the company to bring a novel treatment option with impressive efficacy and a manageable safety profile to appropriate CTCL patients in the European Union,” added Jesus Gomez Navarro, head of Oncology Clinical Research and Development at Takeda.
The drug also has conditional approval for the treatment of adults with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, relapsed or refractory sALCL, or CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.