Detalles de la búsqueda
1.
Blinatumomab for Acute Lymphoblastic Leukemia: The First Bispecific T-Cell Engager Antibody to Be Approved by the EMA for Minimal Residual Disease.
Oncologist
; 25(4): e709-e715, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32297447
2.
EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid Tumors.
Oncologist
; 25(6): e976-e981, 2020 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-32154610
3.
The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid Leukemia.
Oncologist
; 24(5): e171-e179, 2019 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-30898889
4.
ACCELERATE Paediatric Strategy Forums: an advance for oncological drug development?
Lancet Oncol
; 23(11): 1354-1357, 2022 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-36328007
5.
Impact of ACCELERATE Paediatric Strategy Forums: a review of the value of multi-stakeholder meetings in oncology drug development.
J Natl Cancer Inst
; 116(2): 200-207, 2024 Feb 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-37975877
6.
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.
Clin Cancer Res
; 30(11): 2303-2308, 2024 Jun 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-38358393
7.
Paediatric Strategy Forum for medicinal product development of DNA damage response pathway inhibitors in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 190: 112950, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37441939
8.
The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions.
J Clin Oncol
; 40(29): 3456, 2022 10 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-35947814
9.
European regulatory strategy for supporting childhood cancer therapy developments.
Eur J Cancer
; 177: 25-29, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36323049
10.
ACCELERATE - Five years accelerating cancer drug development for children and adolescents.
Eur J Cancer
; 166: 145-164, 2022 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-35290915
11.
Paediatric Strategy Forum for medicinal product development in mitogen-activated protein kinase pathway inhibitors: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 177: 120-142, 2022 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-36335782
12.
Paediatric Strategy Forum for medicinal product development of multi-targeted kinase inhibitors in bone sarcomas: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 173: 71-90, 2022 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35863108
13.
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 160: 112-133, 2022 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34840026
14.
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.
Ther Innov Regul Sci
; 55(6): 1109-1110, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34498227
15.
Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Eur J Cancer
; 157: 198-213, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34536944
16.
Can a Multistakeholder Prioritization Structure Support Regulatory Decision Making? A Review of Pediatric Oncology Strategy Forums Reflecting on Challenges and Opportunities of this Concept.
Clin Pharmacol Ther
; 108(3): 553-556, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32559312
17.
Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 139: 135-148, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32992153
18.
ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients.
Eur J Cancer
; 127: 52-66, 2020 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-31986450
19.
Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Eur J Cancer
; 136: 116-129, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32688206
20.
Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.
J Clin Oncol
; 38(36): 4227-4230, 2020 12 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-32946356