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Janssen/Pharmacyclics drug Imbruvica 2nd FDA 'breakthrough' to cross finish line

 
• By Donna Young

The FDA’s earlier-than-expected approval of Janssen's and Pharmacyclics' Imbruvica (ibrutinib) may be a sign the breakthrough therapy designation is doing its job of expediting the pathway for medicines from development to the marketplace.

The FDA’s earlier-than-expected approval of Janssen's and Pharmacyclics' Imbruvica (ibrutinib) may be a sign the breakthrough therapy designation is doing its job of expediting the pathway for medicines from development to the marketplace.

The drug is only the second with the status to gain the agency's blessing, following Genentech's and Roche's Gazyva (obinutuzumab/GA101), which earlier this month won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL) (scripintelligence.com,

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