David R. Gandara, MD, discusses the current state of tumor mutational burden in lung cancer, ongoing research further examining the utility of this biomarker, and challenges to address with future research. Tumor mutational burden (TMB) possesses the potential to be a strong predictive biomarker of efficacy for checkpoint immunotherapy, although it’s quite complex and has…
Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies. A surge in applications to test and develop new cellular and gene therapies is overwhelming staff at FDA’s Center for Biologics Evaluation and Research (CBER) and prompting calls from manufacturers and research organizations to…
NEW YORK – Friends of Cancer Research will soon release a tumor mutational burden calibration tool that developers of next-generation sequencing assays can use to correct the variability in how TMB is calculated across different gene panels and analysis pipelines. Although this inter-laboratory variability has been expected and observed for some time, FOCR’s TMB harmonization…
Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies looking to be prominent features of the next five-year user fee agreement. Politics likely will play a…
The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports. The agency engaged with the lab and commercial manufacturer communities even before any cases of…
In the first six months of 2020, amid a pandemic, the US Food and Drug Administration approved 21 precision oncology drugs, blowing past the number of approvals during the same period last year and exceeding its total for the full year in 2019. Precision Oncology News defines “precision” cancer drugs as therapies that are…
Harmonizing measurement and reporting of biomarkers in oncology represents a cross-disciplinary challenge that also cuts across industry, regulatory bodies, academic, and clinical practice. As cancer therapy becomes increasingly targeted, the need for validated biomarker measurement becomes more pressing. In first addressing how biomarkers can be used in conjunction with tumor treatment, said Richard Pazdur, MD,…
The House Energy & Commerce Committee on Wednesday (July 15) passed five bipartisan FDA policy bills that would increase the agency’s authority over imported counterfeit medical devices, stop gaming of certain orphan drug exclusivity provisions, boost use of continuous manufacturing, empower FDA to require labeling updates for generic drugs, and allow the agency to add…
The FDA announced a new research project to collect real-world data from insurance companies and electronic health records on the use of diagnostic tests and medications for COVID-19. The agency is partnering with New York–based health tech company Aetion for the project. Together, the FDA and Aetion hope to use advanced analytic techniques to…
A White House effort to undermine Anthony S. Fauci has drawn rebukes from public health experts, scientists and mostly Democratic politicians, who argue it is dangerous for the Trump administration to disparage a highly respected government infectious-disease expert as the novel coronavirus continues to exact a heavy toll on the nation. The angry reaction…
