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FDA starts review of Padcev/Keytruda for bladder cancer

December 1, 2023


The agency is due to deliver a verdict on the combination by 9th May next year and, if approved, it could be an alternative to first-line chemotherapy for all patients with this form of cancer.

Nectin-4-targeting antibody-drug conjugate Padcev (enfortumab vedotin) and PD-1 inhibitor Keytruda (pembrolizumab) already have accelerated approval from the FDA as a first-line option for advanced UC in patients who are ineligible for chemo.

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