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Genentech bags first approval of breakthrough-designated drug in US

This article was originally published in SRA

Executive Summary

Genentech has made history in the US as the first company to have a Food and Drug Administration-designated breakthrough therapy gain market approval. The product is Gazyva (obinutuzumab/GA101), which has won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL)1.

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