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news.The FDA has approved Genentech and Biogen Idec's lymphoma drug Rituxan for use in the first-line treatment of patients with diffuse large B-cell non-Hodgkin's lymphoma, in combination with standard chemotherapy.
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According to Dr Sandra Horning of the Eastern Cooperative Oncology Group, the drug is the first to significantly improve survival for patients with this form of non-Hodgkin’s lymphoma for more than 25 years.
Diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of non-Hodgkin’s lymphoma (NHL), divides and multiplies rapidly in the body, and if left untreated, can be fatal. However, early diagnosis and treatment can improve chances of long-term survival.
The approval in this indication was based on positive data from safety and efficacy trials in 1,854 previously untreated patients with DLBCL.
“The best chance to achieve treatment success is in the first-line setting and these data demonstrate that first-line treatment with up to eight cycles of Rituxan plus chemotherapy resulted in a significant survival advantage in patients with diffuse large B-cell lymphoma,” said Dr Arturo Molina, Biogen Idec’s acting head of medical research, hematology/oncology.
The drug was previously approved in a second-line treatment setting for low-grade or follicular NHL, a less aggressive but usually incurable or indolent form of the disease.