The availability of biosimilars in oncology has provided an opportunity for increased patient access to biologic therapies. However, healthcare professional perceptions concerning the relatively limited clinical data sufficient to support their regulatory approval may contribute to varied uptake and use. We review key aspects of the development program for the rituximab biosimilar PF-05280586 (Ruxience™) that supported its approval for lymphoid malignancies, to illustrate the rationale for an abbreviated clinical program. In particular, we describe the extensive analytical assessment, comprising sensitive techniques that established similarity with the reference product in key product attributes, underlying structure, function, potency, safety and quality, which formed the foundation for a successful development program, culminating in a confirmatory comparative clinical trial in patients with follicular lymphoma.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.2217/fon-2021-0805 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Bispecific Antibodies for Lymphoid Malignancy Treatment.
Cancers (Basel)
December 2024
Hematology Division, A.O.U. Città della Salute e della Scienza di Torino, C.so Bramante 88, 10126 Turin, Italy.
Backgroud: The introduction of highly active immunotherapies has changed the outcome of B-cell non-Hodgkin lymphomas (B-NHLs) in the last two decades. Since then, important progress has been shown using newer and more active immunotherapies, including chimeric antigen receptor T-cell therapy (CAR-T), conjugated monoclonal antibodies, and bispecific antobodies, which currently plays a significant role in the treatment of diffuse large B-cell (DLBCL), follicular (FL), and mantle cell (MCL) lymphoma.
Purpose: In this review, we provide an updated overview of recently completed and ongoing BsAb trials in patients with relapsed/refractory(R/R) B-NHL and Hodgkin's lymphoma, including single-agent results, emerging combinations, safety data, and novel constructs.
Tumor Cell Survival Factors and Angiogenesis in Chronic Lymphocytic Leukemia: How Hot Is the Link?
Cancers (Basel)
December 2024
Centre de Recherche des Cordeliers, Sorbonne Université, Université Paris Cité, Inserm UMRS 1138, Drug Resistance in Hematological Malignancies Team, F-75006 Paris, France.
Chronic lymphocytic leukemia (CLL) is characterized by the accumulation of neoplastic CD5/CD19 B lymphocytes in the blood. These cells migrate to and proliferate in the bone marrow and lymphoid tissues. Despite the development of new therapies for CLL, drug resistance and disease relapse still occur; novel treatment approaches are therefore still needed.
View Article and Find Full Text PDFProposal for Clinical Management of Nodules Diagnosed as Atypia of Undetermined Significance via Thyroid Fine-Needle Aspiration Cytology in the Absence of Molecular Testing.
Cytopathology
January 2025
Department of Internal Medicine, Kuma Hospital, Kobe, Japan.
Objective: Molecular testing is recommended for risk stratification of atypia of undetermined significance (AUS) nodules in the USA; however, it is not routinely performed in some countries owing to limited availability and affordability. Here, we propose a risk stratification algorithm for AUS nodules when molecular testing is unavailable.
Methods: We examined 304 (4.
INDOLENT CLONAL LYMPHOID DISORDERS.
Hum Pathol
January 2025
University Health Network and University of Toronto, Canada.
Indolent clonal lymphoid disorders are not recognized as lymphomas as they generally need no systemic treatment, and depending on the lesion, need only limited clinical follow-up. These lesions are usually incidentally diagnosed during the work up for other disease. The recognition of indolent clonal lymphoid disorders is important to avoid misdiagnosis as lymphoma and unnecessary treatment.
View Article and Find Full Text PDFStructural basis of Epstein-Barr virus gp350 receptor recognition and neutralization.
Cell Rep
January 2025
State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, China. Electronic address:
Epstein-Barr virus (EBV) is an oncogenic virus associated with multiple lymphoid malignancies and autoimmune diseases. During infection in B cells, EBV uses its major glycoprotein gp350 to recognize the host receptor CR2, initiating viral attachment, a process that has lacked direct structural evidence for decades. In this study, we resolved the structure of the gp350-CR2 complex, elucidated their key interactions, and determined the site-specific N-glycosylation map of gp350.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!