Detalhe da pesquisa
1.
U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.
Oncologist
; 24(5): e188-e195, 2019 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-31019020
2.
FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.
Oncologist
; 24(1): 103-109, 2019 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-30120163
3.
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Oncologist
; 24(4): 563-569, 2019 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-30541754
4.
Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.
Pediatr Blood Cancer
; 66(8): e27809, 2019 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-31144772
5.
FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia.
Oncologist
; 23(11): 1366-1371, 2018 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-30018129
6.
FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma.
Oncologist
; 23(6): 734-739, 2018 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-29438096
7.
FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis.
Oncologist
; 23(12): 1511-1519, 2018 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-30115735
8.
FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the BRAFV600 Mutation.
Oncologist
; 23(12): 1520-1524, 2018 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-30120160
9.
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations.
Oncologist
; 23(6): 740-745, 2018 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-29438093
10.
Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.
Oncologist
; 23(4): 496-500, 2018 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-29386313
11.
Regulatory considerations on endpoints in ovarian cancer drug development.
Cancer
; 123(14): 2604-2608, 2017 Jul 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-28499075
12.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.
Oncologist
; 22(11): 1392-1399, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-28835513
13.
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Oncologist
; 22(11): 1347-1353, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-28904172
14.
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.
Oncologist
; 22(7): 873-878, 2017 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-28533473
15.
Breakthrough-Therapy Designation - An FDA Perspective.
N Engl J Med
; 378(15): 1457-1458, 2018 04 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-29641963
16.
NCCN Working Group report: designing clinical trials in the era of multiple biomarkers and targeted therapies.
J Natl Compr Canc Netw
; 12(11): 1629-49, 2014 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-25361808
17.
Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.
Oncologist
; 22(7): 762-767, 2017 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-28576856
18.
The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.
Oncologist
; 15 Suppl 1: 13-8, 2010.
Artigo
em Inglês
| MEDLINE | ID: mdl-20237212
19.
FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma.
Clin Cancer Res
; 25(6): 1702-1708, 2019 03 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-30413526
20.
Complexity of Delivering Precision Medicine: Opportunities and Challenges.
Am Soc Clin Oncol Educ Book
; 38: 998-1007, 2018 May 23.
Artigo
em Inglês
| MEDLINE | ID: mdl-30231318