Results 31 to 40 of about 25,328 (173)

Redefining the Role of Splenectomy in Scirrhous Gastric Cancer: Toward a Selective Multimodal Strategy

Annals of Gastroenterological Surgery, EarlyView.
ABSTRACT Scirrhous gastric cancer, characterized by diffuse infiltration and a high propensity for peritoneal dissemination, remains one of the most aggressive subtypes of gastric cancer. Despite a relatively high incidence of splenic hilar lymph node (No. 10) metastasis, the oncologic benefit of splenectomy remains controversial, while its association
Tsutomu Hayashi, Takaki Yoshikawa
wiley   +1 more source

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

British Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

Durvalumab Treatment Patterns for Patients with Unresectable Stage III Non-Small Cell Lung Cancer in the Veterans Health Administration (VHA): A Nationwide, Real-World Study

Current Oncology, 2023
Background: Durvalumab is approved for the treatment of adults with unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy (CRT).
Amanda M. Moore, Zohra Nooruddin, Kelly R. Reveles, Paromita Datta, Jennifer M. Whitehead, Kathleen Franklin, Munaf Alkadimi, Madison H. Williams, Ryan A. Williams, Sarah Smith, Renee Reichelderfer, Ion Cotarla, Lance Brannman, Andrew Frankart, Tiernan Mulrooney, Kristin Hsieh, Daniel J. Simmons, Xavier Jones, Christopher R. Frei   +18 more
doaj   +1 more source

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

British Journal of Clinical Pharmacology, EarlyView.
Abstract This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders.
Justin L. Hay, Amandine Manon, Hunter Stephens, S. Y. Amy Cheung, Bart de Keizer, Erik T. te Beek   +5 more
wiley   +1 more source

Cost-effectiveness analysis of durvalumab plus tremelimumab as first-line therapy in patients with unresectable hepatocellular carcinoma

Therapeutic Advances in Medical Oncology
Background: The HIMALAYA trial found that durvalumab plus tremelimumab significantly prolonged progression-free survival and overall survival in patients with unresectable hepatocellular carcinoma (HCC) compared with sorafenib.
Weiting Liao, Huiqiong Xu, David Hutton, Qiuji Wu, Yang Yang, Mingyang Feng, Wanting Lei, Liangliang Bai, Junying Li, Qiu Li   +9 more
doaj   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Real-world treatment patterns and outcomes among unresectable stage III non-small cell lung cancer.

PLoS ONE
BackgroundIn 2018, the treatment options for unresectable stage III non-small cell lung cancer (NSCLC) changed with durvalumab, an immune checkpoint inhibitor (ICI), which was approved for consolidation therapy following concurrent chemoradiotherapy ...
Ashwini Arunachalam, Sneha Sura, John Murphy, Paul Conkling, Jerome Goldschmidt   +4 more
doaj   +1 more source

Rationale and design of a phase II trial of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study)

Therapeutic Advances in Medical Oncology, 2020
Background: In the PACIFIC study, progression-free survival (PFS) and overall survival (OS) of patients with unresectable, locally advanced, stage III non-small cell lung cancer (NSCLC) were prolonged by durvalumab as maintenance therapy after radical ...
Tadaaki Yamada, Junji Uchino, Yusuke Chihara, Takayuki Shimamoto, Masahiro Iwasaku, Nobuyo Tamiya, Yoshiko Kaneko, Fumiaki Kiyomi, Koichi Takayama   +8 more
doaj   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Exposure‐Response Analyses of Datopotamab Deruxtecan (Dato‐DXd), a TROP2‐Directed Antibody‐Drug Conjugate, in Advanced Non‐small Cell Lung Cancer

Clinical Pharmacology &Therapeutics, EarlyView.
Exposure‐response analyses supported a favorable benefit‐risk profile of Dato‐DXd at 6 mg/kg Q3W in patients with advanced nonsquamous NSCLC. Datopotamab deruxtecan (Dato‐DXd) is a trophoblast cell‐surface antigen‐2 (TROP2)‐directed antibody‐drug conjugate (ADC) that has demonstrated clinical activity in patients with NSCLC who have received prior ...
Ying Hong, Anna M. Mc Laughlin, Yuzhuo Pan, Sofia Friberg Hietala, Sophie Peigné, Michael Chargualaf, Zoey Tang, Diansong Zhou, Naoyuki Tajima, Malaz Abutarif, Tushar Garimella   +10 more
wiley   +1 more source