AstraZeneca's Imfinzi Debuts In Bladder Cancer With Combo Coming Soon

As many as five PD-1/L1 inhibitors will be approved for second-line metastatic disease by the end of 2017, but AstraZeneca hopes to stand apart with the combination of Imfinzi (durvalumab) with its CTLA-4 inhibitor tremelimumab.

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Approval of the anti-PD-L1 Imfinzi (durvalumab) for second-line bladder cancer represents a major milestone for AstraZeneca PLC in immuno-oncology, but the modest market is very competitive and the drug likely will have to face competition from four other members of its checkpoint family for this indication by the end of the year.

FDA announced accelerated approval for second-line bladder cancer on May 1, six weeks before the drug's user fee date. The approval covers use in patients with locally advanced or metastatic...

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