Foreign
TAKEDA Pharmaceutical Company Limited, “Takeda” has announced that the European Commission, EC, extended the current conditional marketing authorization of ADCETRIS, brentuximab vedotin, to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone). Systemic anaplastic large cell lymphoma is a subtype of peripheral T-cell lymphoma (PTCL).
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.
“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,” said Teresa Bitetti, President, Global Oncology Business Unit. “ 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.”
This approval is based on the results of the Phase 3 ECHELON-2 study evaluating ADCETRIS in combination with CHP to a standard of care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in patients with CD30+ PTCL, including the subtype sALCL.
The study met its primary endpoint with ADCETRIS plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) in the intent to treat population as assessed by an Independent Review Committee (hazard ratio [HR]=0.71; p-value=0.0110).
The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy.
“Clinical outcomes for patients with sALCL have historically been poor; many patients do not achieve long-term survival or remission with the standard of care,” said Eva Domingo-Domenech, MD, Institut Català d'Oncologia – Hospitalet, Hospital Duran i Reynals. “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. 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.”
This decision by the EC means that ADCETRIS is now approved for marketing of this indication in all European Union member states, in addition to Norway, Liechtenstein and Iceland.
– May 17, 2020 @ 17:00 GMT /
Tags: European Commission approves ADCETRIS for Treatment of adult patients
