Takeda’s Adcetris could soon be on the market in Europe as a second-line treatment for adults with CD30-positive cutaneous T-cell lymphoma (CTCL) after regulatory advisors backed expanding the drug’s scope.
In Europe, doctors can currently prescribe Adcetris (brentuximab vedotin) for 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, and to treat adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
The positive CHMP opinion for its use in CTCL represents “a crucial first step” forward for European patients living the disease, said Julia Scarisbrick, Department of Dermatology, University Hospital Birmingham, Birmingham, UK.
“The results of the ALCANZA trial demonstrate impressive efficacy along with a manageable safety profile when compared with methotrexate and bexarotene, commonly used therapies. If approved in Europe, ADCETRIS would offer a novel treatment option for CD30-expressing CTCL patients.”
The trial demonstrated that treatment with Adcetris induced “a highly statistically significant improvement” in the overall response rate lasting at least four months (ORR4) versus the control arm, the data showing 56.3 percent versus 12.5 percent, respectively.
Adcetris, which first received a conditional approval in Europe back in 2012, is an antibody-drug conjugate directed at CD30, which is expressed on skin lesions in around 50 percent of patients with CTCL.
“For patients with CTCL, there is a significant need for additional treatment options that increase the opportunity to achieve durable responses,” said Jesus Gomez Navarro, head of Oncology Clinical Research and Development at Takeda. “We look forward to the European Commission’s review of the CHMP positive opinion of this new indication and the possibility to bring Adcetris to appropriate CTCL patients in the European Union.”