Clinical trial data released earlier this month offered some of the first evidence that measuring tumor mutational burden can help guide the use of cancer immunotherapy not only in advanced cases, but also for patients who have early-stage tumors and a chance of a cure. In the study, which was presented at the annual meeting…
One exciting component of the Food and Drug Administration Safety and Innovation Act was the creation of the breakthrough therapy designation. It allows an all-hands-on-deck approach at the FDA to determine the best path forward when the early clinical promise of a drug is so significant and meaningful beyond existing therapies — or lack of…
Executive Summary Initial draft list of molecular target candidates has industry, investigators and patient advocates asking how the agency intends to prioritize targets and same-in-class molecules for pediatric studies, and how frequently it will update the list; industry representatives divided as to whether ‘broader is better’ when it comes to the target list. The US…
Executive Summary Information about an investigational drug and companion in vitro diagnostics may be submitted in a single investigational new drug application to the agency’s drug or biologics centers, eliminating the need for a separate submission to the device center – unless the diagnostic is determined to be a serious risk, FDA says in draft…
Executive Summary Information about investigational drug and in vitro diagnostic may be submitted in single IND to agency’s drugs or biologics centers, eliminating need for separate submission to devices center; new process should give greater therapeutic context to decisions of whether the IVD is considered a significant risk. The US FDA’s new streamlined approach…
Some cancer physicians say that the requirements to get patients into trials are too onerous and that the criteria should be relaxed, Nature reports. It adds that a meeting is to take place this month between Food and Drug Administration officials and stakeholders to determine whether inclusion criteria prevent patients from getting experimental therapies.…
A new FDA legislative mechanism holds the promise of filling a well-known innovation gap in pediatric cancer drug development, according to speakers at a meeting on molecularly targeted cancer therapies for children and adults hosted by the Friends of Cancer Research (FOCR) in Washington, D.C. The organization produced a background paper on the topic (not…
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), said she “live[s] in fear” of providers using outdated treatment methods based on FDA-approved drug labels which, the director admitted, are updated less and less after FDA first approves a drug. Woodcock made clear that FDA cannot play an omnipresent role in making…
The Medicare program’s decision to cover personalized medicine tests for cancer patients earned praise from industry groups and others, but one cancer research advocacy group told me the government insurer could have done more to help researchers understand how well the tests work. The Centers for Medicare & Medicaid Services said March 16 it…
Nearly 20% of publicly funded cancer clinical trials in the United States fail because investigators are unable to enrol enough participants. Yet patients and their physicians often grow frustrated when they encounter the sometimes insurmountable requirements to join a study. Now, researchers are pruning the lengthy lists of eligibility criteria for trials, in the…
