According to a story from BioPortfolio, Takeda Pharmaceutical Company Limited recently announced that its drug ADCETRIS (brentuximab vedotin) has seen its marketing authorization extended in the European Union. The European Commission has agreed to expand the drug’s indication to include adults with stage IV Hodgkin’s Lymphoma that has not been previously treated. Their disease must also test positive for CD30, a biomarker for the disease.
About Hodgkin’s Lymphoma
Hodgkin’s lymphoma is a form of blood cancer that affects a type of white blood cell called a lymphocyte. Around half of Hodgkin’s lymphoma cases are linked to infection by the Epstein-Barr virus. In the remaining cases a precise cause is often unknown. Symptoms of Hodgkin’s lymphoma include kidney damage, swollen lymph nodes, fever, itching, red skin patches called petechiae, bleeding, night sweats, back pain, enlarged spleen and/or liver, and pain after drinking alcohol. Treatment for Hodgkin’s lymphoma usually include chemotherapy and radiation therapy. In early stages, curing the disease is possible with these treatments. More advanced disease is usually treated with combination chemotherapy. A number of different chemotherapy regimens have been developed for the disease. Treatment can lead to serious long term adverse effects. Long term survival is possible for most patients; the five year survival rate is 86 percent in the US. To learn more about Hodgkin’s lymphoma, click here.
Improving The Odds For Patients With Advanced Disease
The new expansion is the first new treatment for patients with untreated advanced Hodgkin’s lymphoma in decades. The approval comes after positive results from a Phase 3 trial in which ADCETRIS was substituted in place of bleomycin as part of the ABVD chemotherapy regimen. When compared to the ABVD combination with bleomycin, patients saw a 23 percent reduction in risk of death, need for other treatment, or progression of their disease. The safety profile of ADCETRIS plus AVD was also unchanged in comparison to the ABVD regimen.
ADCETRIS gives patients with stage IV Hodgkin’s lymphoma a new reason for optimism about their treatment outcome. The drug has also been previously approved to treat mycosis fungoides, anaplastic large cell lymphoma, and other forms of lymphoma that express the CD30 biomarker.