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05-09-2018 | FDA | News

approvalsWatch

PD-L1 diagnostics approved for pembrolizumab, atezolizumab use in urothelial cancer

medwireNews: US patients who require first-line use of pembrolizumab or atezolizumab for the treatment of locally advanced or metastatic urothelial cancer must now be tested for PD-L1 tumor expression using an approved companion diagnostic.

The FDA has approved the use of the PD-L1 immunohistochemistry 22C3 PharmDx Assay (Dako North America, Inc) for patients being considered for treatment with pembrolizumab. The PD-1 inhibitor may be used for patients with a PD-L1 combined positive score of 10 or above who are not eligible for cisplatin, and for patients who are unsuitable for any form of platinum chemotherapy, regardless of PD-L1 score.

Similarly, the FDA has approved the use of the PD-L1 SP142 Assay (Ventana Medical Systems, Inc) as a companion diagnostic to identify patients eligible for atezolizumab. The PD-L1 inhibitor may be given to cisplatin-ineligible patients who have at least 5% staining of tumor-infiltrating immune cells, as well as patients who are ineligible for platinum-based chemotherapy.

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The US FDA has now given regular approval for the first-line use of pembrolizumab with chemotherapy for patients with metastatic nonsquamous non-small-cell lung cancer. This follows accelerated approval for this indication in 2017. 12282962

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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