Metastasis-free Survival — A New End Point in Prostate Cancer Trials

Metastasis-free Survival — A New End Point in Prostate Cancer Trials

The FDA’s approval of apalutamide for use in nonmetastatic castration-resistant prostate cancer (nmCRPC) was based on an improvement in metastasis-free survival. It was the first drug approval for nmCRPC and the first use of this primary end point to support drug approval.

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Bibliographische Detailangaben
Veröffentlicht in:The New England journal of medicine 2018-06, Vol.378 (26), p.2458-2460
Hauptverfasser: Beaver, Julia A, Kluetz, Paul G, Pazdur, Richard
Format: Artikel
Sprache:eng
Schlagworte:
Androgens
Antigens
Cancer therapies
Castration
Colon
Committees
Design
Disclosure
Drugs
FDA approval
Illnesses
Medical imaging
Metastases
Metastasis
Prostate cancer
Survival
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Zusammenfassung:The FDA’s approval of apalutamide for use in nonmetastatic castration-resistant prostate cancer (nmCRPC) was based on an improvement in metastasis-free survival. It was the first drug approval for nmCRPC and the first use of this primary end point to support drug approval.
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMp1805966