New Market For Genentech's Gazyva: Follicular Lymphoma
This article was originally published in Scrip
Roche AG unit Genentech Inc. won the FDA's approval to market Gazyva (obinutuzumab) as a treatment for follicular lymphoma, the most common type of indolent non-Hodgkin's lymphoma (NHL), accounting for about one in five cases of the disease.
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Roche's Gazyva/Gazyvaro missed its primary endpoint in a Phase III study in first-line diffuse large B-cell lymphoma, failing to score a treble in lymphoma indications for the product, which the company is relying on to replace revenues from the increasingly biosimilared rituximab. The failure has also brought to investors' minds the larger uncertainty over Perjeta's future in breast cancer in the APHINITY study.
Roche has caught investors off guard with the early announcement that its Phase III GALLIUM study of Gazyva in first-line follicular lymphoma has reached its primary endpoint of progression-free survival when pitted against the company's own standard-of-care treatment MabThera.