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1.
Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials.
Blood
; 142(3): 235-243, 2023 07 20.
Article
in English
| MEDLINE | ID: mdl-37140031
2.
Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis.
Lancet Oncol
; 25(4): 455-462, 2024 Apr.
Article
in English
| MEDLINE | ID: mdl-38458207
3.
FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial.
Oncologist
; 27(2): 149-157, 2022 03 04.
Article
in English
| MEDLINE | ID: mdl-35641211
4.
FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy.
Oncologist
; 27(6): 493-500, 2022 06 08.
Article
in English
| MEDLINE | ID: mdl-35363318
5.
FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.
Pediatr Blood Cancer
; 69(8): e29602, 2022 08.
Article
in English
| MEDLINE | ID: mdl-35561013
6.
Impact of an evolving regulatory landscape on skin cancer drug development in the U.S.
Dermatol Online J
; 28(2)2022 Mar 15.
Article
in English
| MEDLINE | ID: mdl-35670678
7.
Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.
Lancet Oncol
; 22(11): 1573-1581, 2021 11.
Article
in English
| MEDLINE | ID: mdl-34656225
8.
Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials.
Lancet Oncol
; 22(9): 1230-1239, 2021 09.
Article
in English
| MEDLINE | ID: mdl-34310904
9.
Oncology Expanded Access and FDA's Project Facilitate.
Oncologist
; 26(10): e1880-e1882, 2021 10.
Article
in English
| MEDLINE | ID: mdl-34288259
10.
FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma.
Oncologist
; 26(3): e484-e491, 2021 03.
Article
in English
| MEDLINE | ID: mdl-33044793
11.
Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.
Oncologist
; 26(4): 318-324, 2021 04.
Article
in English
| MEDLINE | ID: mdl-33345396
12.
FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Oncologist
; 26(10): 879-886, 2021 10.
Article
in English
| MEDLINE | ID: mdl-34132444
13.
FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib.
Oncologist
; 26(9): 797-806, 2021 09.
Article
in English
| MEDLINE | ID: mdl-33973307
14.
Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.
Oncologist
; 26(10): e1786-e1799, 2021 10.
Article
in English
| MEDLINE | ID: mdl-34196068
15.
FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.
Oncologist
; 26(5): 433-438, 2021 05.
Article
in English
| MEDLINE | ID: mdl-33687763
16.
FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer.
Oncologist
; 26(1): e164-e172, 2021 01.
Article
in English
| MEDLINE | ID: mdl-33017510
17.
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer.
Oncologist
; 26(2): 139-146, 2021 02.
Article
in English
| MEDLINE | ID: mdl-33145877
18.
US Food and Drug Administration regulatory updates in neuro-oncology.
J Neurooncol
; 153(3): 375-381, 2021 Jul.
Article
in English
| MEDLINE | ID: mdl-34156585
19.
CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis.
Lancet Oncol
; 21(2): 250-260, 2020 02.
Article
in English
| MEDLINE | ID: mdl-31859246
20.
Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.
Oncologist
; 25(4): 348-354, 2020 04.
Article
in English
| MEDLINE | ID: mdl-32297444