The European Commission (EC) has approved Adcetris (brentuximab vedotin) when used alongside chemotherapy as a first treatment for adults with systemic anaplastic large cell lymphoma (sALCL), a type of peripheral T-cell lymphoma (PTCL).
The decision to extend Adcetris’ current approval came after the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), recommended it for this indication in late March.
Adcetris can now be given to treatment naive people with sALCL in all European Union member countries, as well as in Norway, Liechtenstein, and Iceland.
Jointly developed by Millennium Pharmaceuticals (now part of Takeda Pharmaceuticals) and Seattle Genetics, Adcetris is an antibody-drug conjugate that works by binding to CD30, a protein found on the surface of cancer cells.
Once bound, it releases a toxic compound called monomethyl auristatin E (MMAE) that works to prevent cancer cell division and expansion.
The medication is approved to treat different types of lymphoma in more than 65 countries, including the U.S. In the EU, Adcetris has been approved for five indications, including adults with relapsed or refractory sALCL.
“The European Commission’s decision to approve Adcetris for the first-line treatment of patients with sALCL marks a significant milestone for people diagnosed with this devastating condition,” Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, said in a press release.
“Adcetris is the first and only targeted therapy that has been approved in first-line sALCL in several decades. Takeda remains steadfast in our commitment to deliver life changing treatment options to cancer patients worldwide and we are thrilled to have the opportunity to bring this new option to the lymphoma community in Europe,” Bitetti said.
The EC’s decision to approve Adcetris in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, and prednisone) as a treatment for sALCL patients who have not had prior therapies was based on data from the Phase 3 ECHELON-2 (NCT01777152) trial.
ECHELON-2 was designed to compare Adcetris plus CHP chemotherapy versus standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy in 452 patients with CD30-positive PTCL, which also included those with sALCL.
Previous trial data showed that Adcetris in combination with CHP reduced the risk of disease progression or death by 29% in the overall patient population compared to standard CHOP.
The combo therapy also led to significant improvements to CHOP in other key secondary endpoints, including patients’ overall survival and response to treatment.
Its safety profile was similar to CHOP and consistent with that of Adcetris when used alongside cancer-killing agents.
“The data from ECHELON-2 showed impressive results for patients treated with Adcetris plus CHP compared to a standard of care, all while maintaining a comparable safety profile,” said Eva Domingo-Domenech, MD, with the Institut Català d’Oncologia — Hospitalet, Hospital Duran i Reynals in Barcelona.
“The approval of Adcetris in previously untreated sALCL brings a much needed treatment option to the PTCL community, and I am pleased to be able to offer Adcetris as a first-line option to eligible European patients,” Domingo-Domenech added.
