Public health agency The US Food and Drug Administration reported on Tuesday that it has approved Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
The US FDA has awarded the approval of Adcetris to Seattle Genetics Inc following the a priority review and breakthrough therapy designations.
Lymphoma is a cancer that begins in the lymph system. Lymphoma can begin almost anywhere in the body and can spread to nearby lymph nodes. The two main types of lymphoma are Hodgkin lymphoma (also called Hodgkin disease) and non-Hodgkin lymphoma.
Adcetris combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. The new treatment is an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago.
This US FDA approval for adult patients with previously untreated stage III or IV cHL was based on the company's clinical trial with of 1,334 patients, comparing Adcetris plus chemotherapy (Adriamycin [doxorubicin], vinblastine and dacarbazine, or AVD) to a chemotherapy-only regimen common for cHL treatment (AVD plus bleomycin, also known as ABVD).
According to the company, the trial measured modified progression-free survival (mPFS), under which, about 117 (18%) patients on the Adcetris plus AVD arm who experienced disease progression, death, or began new therapy compared to 146 (22%) patients on the ABVD arm.
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