| Autor: |
Steven Lemery, Lola Fashoyin-Aje, Leigh Marcus, Sandra Casak, Julie Schneider, Marc Theoret, Paul Kluetz, Richard Pazdur, Julia A. Beaver |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Annual Review of Cancer Biology. 6:147-165 |
| ISSN: |
2472-3428 |
| Popis: |
In 2017 the FDA (US Food and Drug Administration) approved pembrolizumab, a programmed death 1 (PD-1) inhibitor, for the treatment of unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors, regardless of tumor site or histology. This represented the first approval based on the identification of a biomarker and independent of tumor site. Although this approach may intuitively appear rational, tissue-agnostic drug development can be complicated by tumor-specific resistance mechanisms or other factors that can alter a drug's effect. Inherent with the tissue-agnostic approach is the fact that there may be residual uncertainty concerning a drug's effect in unstudied tumor types (e.g., at the time of approval). However, this approach may be the only available mechanism to support approval and provide access to a drug that is indicated for the treatment of patients with certain rare biomarker-positive cancers. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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