EMA and FDA prune the checkpoint inhibitor treatment landscape Journal Article
| Authors: | Teo, M. Y.; Rosenberg, J. E. |
| Article Title: | EMA and FDA prune the checkpoint inhibitor treatment landscape |
| Abstract: | 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. © 2018, Springer Nature Limited. |
| Keywords: | cancer survival; protein expression; treatment outcome; overall survival; drug approval; note; methodology; medical decision making; tumor associated leukocyte; protein analysis; food and drug administration; cancer research; transitional cell carcinoma; drug indication; programmed death 1 ligand 1; phase 3 clinical trial (topic); cancer prognosis; human; priority journal; pembrolizumab; atezolizumab; european medicines agency |
| Journal Title: | Nature Reviews Urology |
| Volume: | 15 |
| Issue: | 10 |
| ISSN: | 1759-4812 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2018-10-01 |
| Start Page: | 596 |
| End Page: | 597 |
| Language: | English |
| DOI: | 10.1038/s41585-018-0074-1 |
| PUBMED: | 30116057 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Note -- Export Date: 1 November 2018 -- Source: Scopus |
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