Background on dose-finding in oncology In the early phases of clinical development of oncology products, sponsors conduct dose-finding studies to determine the maximum tolerated dose (MTD) of an investigational product. MTD seeks to find the tolerability and safety of treatment at the highest dose that can both be tolerated and treat the cancer. There are several…
Circulating tumor (ct)DNA may serve as an early predictor of treatment response with immune checkpoint inhibitors for patients with non-small cell lung cancer (NSCLC), researchers reported. Mark Stewart, PhD, of Friends of Cancer Research in Washington, D.C., and colleagues assessed the role of ctDNA for monitoring response to immune checkpoint inhibitors through a standardized approach…
In a surprising move, GSK recently pulled multiple myeloma therapy Blenrep off the U.S. market just 15 days after the drug flunked a confirmatory trial. The product pull came at the request of the FDA, and the company’s speedy action prompted industry watchers to wonder if there’s a new benchmark for removing indications under the agency’s accelerated…
Rise in healthcare spending has fast-tracked progress in telehealth, vaccines and precision medicine, but businesses and policy-makers must tackle worker burnout and boost access to health A new report, Global Health and Healthcare Strategic Outlook, addresses misinformation, funding challenges, mental health, inequities, workforce shortages, supply chains, climate impacts and macroeconomic instability The fastest vaccine development in…
In 1971, when the National Cancer Act was signed, J. Palmer Saunders was the director of the Division of Cancer Research, Resources and Centers. On July 22, 1998 as part of the NCI Oral History Project interviews, he described his work at NCI, his career, and the time he was asked to investigate NCI’s Chemotherapy…
The Friends of Cancer Research (FOCR) held its 15th annual meeting in Washington, DC, focusing on strategies to make cancer clinical trials simpler, less cumbersome, more diverse and accessible, and more patient-centered. The conference featured keynote speakers, along with panelists who participated in writing three new white papers presented at the meeting. They includeed the…
NEW YORK – Despite a lot of talk that 2022 was going to be the year that finally brought a legislative solution to the question of whether the US Food and Drug Administration can regulate lab-developed tests, the VALID Act was scuttled from inclusion in a must-pass spending bill at the end of December. VALID sought to end the…
S2302 Pragmatica-Lung is a federally-funded, streamlined clinical trial examining a new combination of agents in patients with advanced non-small cell lung cancer (NSCLC). Like most studies, it is focused on improving outcomes for patients with cancer—but it is also poised to simplify and transform the entire clinical trials model as we know it. S2302 Pragmatica-Lung…
Legislation that would have overhauled regulation of diagnostics and laboratory developed tests fell off the omnibus after House Energy and Commerce ranking member Cathy McMorris Rodgers (R-Wash.) led efforts to block the provision. “It pretty single handedly was her and her staff that killed the deal in spite of it being bipartisan,” a person familiar with negotiations granted anonymity…
The FDA’s Oncology Center of Excellence has completed the first “Project Renewal” update to the labeling of an older generic cancer drug with additional indications and dosing regimens for Genentech, Inc.’s Xeloda (capecitabine). In 2018, officials began discussing the need to update the labeling of older, commonly prescribed oncology drugs to ensure they reflect current practice.…
