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APPROVED: Genentech/Roche Gazyva 1st breakthrough-designated drug to enter US market

This article was originally published in Scrip

Executive Summary

Roche US unit Genentech made history on 1 November as the first company to have an FDA-designated breakthrough therapy gain th agency’s blessing to enter the US market – Gazyva (obinutuzumab/GA101), which won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL).

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