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http://dx.doi.org/10.1177/1932296816648991 | DOI Listing |
Cureus
December 2024
Clinical Research and Medical Writing, Meril Life Sciences Private Limited, Vapi, IND.
Aim The primary objective of the study was to evaluate the mid-term implant survivability, rate of revisions, and clinical and functional outcomes following patella resurfacing during total knee arthroplasty (TKA) utilizing posterior stabilized (PS) total knee system (TKS). Methods A prospective, single-arm, multi-center, post-marketing surveillance encompassed patients with end-stage primary knee osteoarthritis (OA) or inflammatory arthritis. The time points of the study included baseline, six weeks, six months, one year, and three years post-operatively.
View Article and Find Full Text PDFClin Cancer Res
January 2025
United States Food and Drug Administration, Silver Spring, Maryland, United States.
On April 23, 2024, FDA granted accelerated approval to tovorafenib, a type II RAF kinase inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Efficacy was evaluated in FIREFLY-1 (NCT04775485), a single-arm, open-label, multicenter trial that enrolled patients 6 months to 25 years of age with relapsed or refractory pLGG with an activating BRAF alteration who had received prior systemic therapy. The major efficacy outcome measure was radiologic overall response rate (ORR), defined as the proportion of patients with complete response, partial response, or minor response as determined by blinded independent central review using Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.
View Article and Find Full Text PDFClin Transl Sci
January 2025
College of Pharmacy, Daegu Catholic University, Gyeongsan, Korea.
Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates.
View Article and Find Full Text PDFEur J Nucl Med Mol Imaging
January 2025
Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea.
Purpose: Estrogen receptor (ER) expression and heterogeneity affect endocrine therapy efficacy. F-fluoroestradiol (F-FES) PET/CT is an effective non-invasive method to analyze systemic ER expression. This study aimed to examine the predictive/prognostic value of F-FES PET/CT for patients treated with endocrine therapy plus cyclin-dependent kinase 4/6 (CDK4/6) inhibitors.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
January 2025
Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Background: Cancer medicines usually have uncertain efficacy and safety profiles when they are first approved by medicines regulators because this evidence usually emerges post-market. Little is known about the extent to which post-market evidence is evaluated and integrated into evidence review processes in regulatory and clinical contexts.
Objectives: The objective of this scoping review is to examine the literature on how post-market evidence on benefits and harms is evaluated and integrated in regulatory decisions and guidance for clinical decision-making.
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