NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

anders, you have repeatedly asserted that it will be necessary to run trials for every organ-specific cancer, and that is completely outdated and WRONG. The FDA has approved, and will approve a treatment for cancer in ANY location in the body based on genetic or other type of biomarker that the treatment has been proven to work for in clinical trials. This first occurred with Keytruda back in 2017, and Keytruda was just approved again this June based on another biomarker.

This latest approval was very significant as it relates to Northwest Bio because DCVax has proven to be particularly effective based upon that same biomarker - ALL cancers with a high Tumor Mutational Burden (TMB). TMB is a measure of the number of gene mutations inside the cancer cells, which can be determined by a lab test. Cells that have many gene mutations (a high TMB) might be more likely to be recognized as abnormal and attacked by the body’s immune system. It’s very likely that this trial in Glioblastoma will identify other biomarkers in the long-lived patients in the survival tail, which will be used to expand the label to ALL cancers in the body with this biomarker.

Biomarkers at FDA

Biomarkers are a key medical product development tool capable of facilitating development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treatments by reducing the time and cost of clinical trials while maintaining patient protections.

FDA is working to help speed the development of promising new therapeutics by developing regulatory science standards, reference libraries, research methods, and tools that are needed for integrating biomarker information into medical product development and clinical decision-making. . . .

https://www.fda.gov/science-research/about-science-research-fda/biomarkers-fda



FDA Approves Pembrolizumab for Tumors with Specific Genetic Features

https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-pembrolizumab-genetic-features



FDA Approves Second Biomarker-Based Indication for Merck’s KEYTRUDA® (pembrolizumab), Regardless of Tumor Type

https://finance.yahoo.com/news/fda-approves-second-biomarker-based-104500734.html