Approvals in 2022: overall survival, dose optimization, new approvals and beyond

被引:2
作者
Telaraja, Deepti [1 ]
Gormley, Nicole [1 ]
Pazdur, Richard [2 ]
机构
[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[2] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA
关键词
INHIBITORS;
D O I
10.1038/s41571-023-00741-6
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
In 2022, the FDA approved numerous new drug and biologic agents, including targeted small molecules, immunotherapeutics, a gene therapy and a radiopharmaceutical. Several drug development challenges were also addressed, and key focus areas for the FDA Oncology Center of Excellence included ongoing monitoring of the Accelerated Approval programme and drug dose optimization.
引用
收藏
页码:207 / 208
页数:2
相关论文
共 6 条
[1]  
FDA, 2022, ONC CTR EXC GUID DOC
[2]  
FDA, CONV CANC
[3]  
FDA, 2022, ONC DRUGS ADV COMM O
[4]   The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint [J].
Richardson, Nicholas C. ;
Kasamon, Yvette ;
Pazdur, Richard ;
Gormley, Nicole .
LANCET ONCOLOGY, 2022, 23 (05) :563-566
[5]  
Secura Bio Inc., 2022, FEDREG
[6]   Poly(ADP-Ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: ASCO Guideline Rapid Recommendation Update [J].
Tew, William P. ;
Lacchetti, Christina ;
Kohn, Elise C. .
JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (33) :3878-+