Category: In the News

At the recent American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Janet Espirito, PharmD, a Senior Medical Director at Ontada, sat down with Oncology Data Advisor to discuss her presentation on identifying real-world end points for assessing response in patients receiving novel therapies for metastatic non–small cell lung cancer (NSCLC) outside of clinical trials. Oncology…

Circulating tumor DNA has the potential to not only change the way medical oncologists assess and treat cancer patients, but also how cancer drugs are reviewed, oncology experts at FDA and pharmaceutical companies said in response to research findings published July 11 by a collaboration led by Friends of Cancer Research. To date, the Friends…

Laboratory-developed tests may be misidentifying patients for treatment with targeted therapies. Under a new initiative, the FDA will work with sponsors to develop minimum performance characteristics for LDTs that may be used with an approved cancer drug in clinical practice. The US Food and Drug Administration’s pilot program for oncology drugs and in vitro diagnostic…

Senior Centers for Medicare and Medicaid Services official Lee Fleisher described the game plan behind the CMS-facilitated patient registry for the new Alzheimer’s disease treatment, but former CMS official Sean Tunis is still concerned the approach won’t meet data expectations in the planned two-year window. The Centers for Medicare and Medicaid Services will link Medicare…

Can clinical trials in renal cell carcinoma (RCC) be more inclusive of patient populations? Do we know what matters most to kidney cancer patients in treatment selection and follow-up? Are oncologists primarily responsible for patient education in community-based care of RCC—or is it someone else? How does the patient experience differ from one country to…

As researchers consider using circulating tumor DNA as an endpoint in clinical trials to evaluate drug efficacy, a collaboration led by Friends of Cancer Research is creating the evidentiary roadmap for the use of ctDNA in regulatory decisions. As tumor cells, small pieces of DNA are released into the bloodstream, and detectable levels of ctDNA…

This articles aims to drive understanding in Antibody Drug Conjugate (ADC) drug development to improve patient outcomes. Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. The authors also explore the need for further data to improve understanding and…

Janet L. Espirito, PharmD, Senior Medical Director for Ontada, speaks with the Journal of Clinical Pathways about the significance of her research on real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets. The study was presented at the 2023 ASCO Annual Meeting in Chicago, IL. Can you give some background about your study…

There is general agreement that the eligibility criteria in cancer clinical trials need to be broadened. Doing so would not only increase the number of patients enrolled in protocol-driven, investigational treatment plans, but also improve the generalizability of results. In 2021, ASCO and Friends of Cancer Research published recommendations for broadening the eligibility criteria for cancer trial…

The Center for Biologics Evaluation & Research wants to publish guidance documents in “real time” and find ways to work more collaboratively with sponsors on fast-moving areas of drug development like cell therapies, while still being able to “hold ourselves accountable” as regulators, CBER Director Peter Marks said. “We are trying to take a page…