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Roche says EU panel backs lymphatic cancer drug for approval
January 24, 2014 / 5:06 PM / 4 years ago

Roche says EU panel backs lymphatic cancer drug for approval

ZURICH (Reuters) - Swiss drug company Roche said on Friday a European Union committee recommended its MabThera subcutaneous treatment for patients with non-Hodgkin lymphoma.

Roche said the opinion of the EU Committee for Medicinal Products for Human Use (CHMP) was based primarily on data from a phase III study, with a final decision from the European Commission expected in coming months.

The Commission generally follows committee recommendations, though it is not obliged to.

MabThera is a treatment for non-Hodgkin lymphoma, a cancer of the lymphatic system, and is currently delivered by an intravenous infusion which takes 2-1/2 hours to complete.

In contrast, the new MabThera subcutaneous formulation can be delivered over approximately five minutes, Roche said.

Reporting by Alice Baghdjian

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