This site is intended for healthcare professionals
News

CHMP recommends extension of approval for Adcetris plus CHP in anaplastic large cell lymphoma.- Takeda Pharma

Read time: 1 mins
Published:1st Apr 2020
Takeda Pharmaceutical Co announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with CHP (cyclophosphamide, doxorubicin, prednisone) as a treatment for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). The positive CHMP opinion is based on the results of the Phase III ECHELON-2 study evaluating Adcetris in combination with CHP to a standard care, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in previously untreated patients with CD30+ peripheral T-cell lymphoma (PTCL), including the subtype sALCL. Adcetris is an antibody-drug conjugate (ADC) directed at CD30, which is expressed on the surface of several types of PTCL, including sALCL. The ECHELON-2 study met its primary endpoint with Adcetris plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) as assessed by an Independent Review Committee (hazard ratio [HR]=0.71; p-value=0.0110), 29 percent improvement in PFS. 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.
Condition: Lymphoma. systemic anaplastic large cell
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.