The On- and Off-Ramps of Oncology Accelerated Approval

N Engl J Med. 2022 Oct 20;387(16):1439-1442. doi: 10.1056/NEJMp2208954. Epub 2022 Sep 21.

Authors

Lola A Fashoyin-Aje¹, Gautam U Mehta¹, Julia A Beaver¹, Richard Pazdur¹

Affiliation

¹ From the Office of Oncologic Diseases, Center for Drug Evaluation and Research (L.A.F.-A., G.U.M., J.A.B., R.P.), and the Oncology Center of Excellence (L.A.F.-A, J.A.B., R.P.), Food and Drug Administration, Silver Spring, MD.

PMID: 36129992
DOI: 10.1056/NEJMp2208954

No abstract available

MeSH terms

Drug Approval*
Humans
Medical Oncology*
Neoplasms* / drug therapy
United States
United States Food and Drug Administration