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

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).