Roche's Gazyvaro granted European Commission approval for leukemia

Swiss drug major Roche (ROG: SIX) has announced that its drug Gazyvaro (obinutuzumab) has been approved by the European Commission in combination with chlorambucil chemotherapy for the treatment of previously untreated lymphocytic leukemia with comorbidities making them unsuitable for an intensive therapy. Gazyvaro is marketed as Gazyva outside of the EU and Switzerland.

The approval is based on the Phase III study showing Gazyvaro with chlorambucil chemotherapy significantly extended the amount of time people lived without the disease worsening, while increasing the depth of their remissions compared to standard treatments such as chlorambucil, or MabThera plus chlorambucil.

Sandra Horning, Roche’s chief medical officer and head of global product development, said: “Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.”