Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation

Anticancer drugs, Clinical trials, Drug approval, Immune checkpoint inhibitors, Publications, United states food and drug administration

  The study investigates the publication status of clinical trials for anticancer drugs approved by the FDA, focusing on immune checkpoint inhibitors (ICPis). Data from ICPis approved between 2011 and 2014 was analyzed, revealing that 58% of ICPis trials were published within two years …

Oct 24^th • 18 mins read

Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology

bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach

Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…

Jun 24^th • 18 mins read

Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology

immuno-oncology, mechanistic models, tumor vs. immune system, systems pharmacology, pharmacokinetics, pharmacodynamics, molecular and cellular biomarkers

There has been significant growth in the development of immuno-modulating pharmacological treatments for various cancers following the approval of the first immune checkpoint inhibitor. Challenges in immuno-oncology (IO) drug development are complex and span from the discovery phase to late-…

Apr 30^th • 12 mins read

Biosimilars in Oncology: Latest Trends and Regulatory Status

oncology, biologics, biosimilars, regulatory framework, traceability

Biologic-based medicines are crucial in treating various diseases, particularly cancer, and hold a significant portion of the global pharmaceutical market. Biosimilars, which are highly similar to biologic drugs but not identical, offer potential benefits such as enhanced access and cost savings,…

Dec 5^th • 20 mins read

Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs

checkpoint inhibitor drugs, immunotherapy drugs, FDA, checkpoint, inhibitor, drugs

If FDA-approved checkpoint inhibitor drugs are universally available, we estimated that the proportion of US patients with cancer who could be eligible for such drugs is approximately 44%, while approximately 13% have a response to these drugs. These estimates, although modest, are better than estim…

May 3^rd • 10 mins read