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EMA and FDA prune the checkpoint inhibitor treatment landscape

Nature Reviews Urology volume 15, pages 596–597 (2018)Cite this article

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The European Medicines Agency (EMA) and FDA have recently restricted the indications for first-line pembrolizumab and atezolizumab to patients with programmed cell death 1 ligand 1 (PD-L1)-high advanced urothelial carcinoma, a decision made following interim analyses from the ongoing Keynote-361 and IMvigor130 phase III trials. Questions remain on the magnitude of inferior survival and standardized implementation of PD-L1 testing.

Refers to European Medicines Agency. EMA restricts use of Keytruda and Tecentriq in bladder cancer. EMA http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/05/WC500249798.pdf (2018).

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References

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Affiliations

  1. Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

    Min Yuen Teo & Jonathan E. Rosenberg

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  1. Min Yuen Teo
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  2. Jonathan E. Rosenberg
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Correspondence to Jonathan E. Rosenberg.

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Competing interests

J.E.R has received consulting fees from Genentech/Roche, AstraZeneca, Bristol-Myers Squibb (BMS), Seattle Genetics, Merck, Bayer, EMD Serono, Astellas, and Mirati Research; funding (for industry trials) from Genentech/Roche, Astellas, and Bayer; and research funding (investigator-initiated trial) from Novartis and Genentech/Roche. M.Y.T. has received research funding (IIT) from BMS.

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Teo, M.Y., Rosenberg, J.E. EMA and FDA prune the checkpoint inhibitor treatment landscape. Nat Rev Urol 15, 596–597 (2018). https://doi.org/10.1038/s41585-018-0074-1

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