Category: In the News

An analysis conducted by Friends of Cancer Research showed that the FDA Breakthrough Therapy Designation criteria select drugs that lead to better outcomes for patients with lung cancer. The study, titled “Breakthrough Therapy Designation Criteria Identify Drugs that Improve Clinical Outcomes for Patients: A Case for More Streamlined Coverage of Promising Therapies,” was published in Clinical Cancer…

The evening of May 10, 2022, the Friends of Cancer Research held their 25th Anniversary Dinner Celebration at the Four Seasons Hotel in Washington, DC. As part of the event, they recognized 25 scientific and advocacy leaders who, through their work and partnership, have been instrumental over the course of the last 25 years in…

Following in the footsteps of the cytokine interleukin (IL)-2, IL-15 affords investigators similar qualities as a target without the associated toxicities of its immunotherapeutic predecessor.1 Because IL-15 represents a potential potent immune modulator, leveraging its ability to activate effector T and natural killer (NK) cells may rely on the development of immune cytokines with additional antibodies…

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur Rahman, PhD, Director, Division of Cancer Pharmacology II, Center for Drug Evaluation and Research, FDA; Marc R. Theoret, MD,…

Multi-cancer early detection screening tests from a sample of blood (liquid biopsy) can detect cancer signals at very early stages, leading to the hope of earlier treatments that may be more effective and even curative. Currently, standard-of-care screening tests exist for only a limited number of cancers, and each is designed to detect only a…

The FDA could remove from the market any drugs that obtained accelerated approval if they fail to show a clinical benefit under a proposed package reauthorizing must-pass user fee legislation. The bipartisan proposal, unveiled Wednesday by leaders of the House Energy and Commerce Committee, would push sponsors of drugs approved through the accelerated pathway to…

Circulating tumor DNA (ctDNA) can be used as a biomarker in early-stage solid tumor clinical trials for purposes of patient selection, patient enrichment and as a measure of response. However, further data are needed to support use as an endpoint reasonably likely to predict long-term outcome, the US Food and Drug Administration said. In a…

FDA draft guidance issued Monday endorses ctDNA as a biomarker in drug development for early-stage, non-metastatic solid tumors, and lays out the agency’s thinking on its uses and limitations in four broad areas: patient selection based on molecular alteration, risk assessment based molecular residual disease, response measurement, and as an early endpoint for clinical trials.…

Finding the MTD, or maximum tolerated dose, was a rarely challenged rule in trials of cytotoxic drugs. But drugs change—and ideologies change with them. Today, a growing number of oncologists, drug developers, patient activists, and FDA officials are calling for setting the dose by means more refined than a sledgehammer. “There are other models besides…

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced today that the first participants have been enrolled in a study that is part of an 800-site master protocol trial for non-small cell lung cancer (NSCLC). The Lung Cancer Master Protocol trial (Lung-MAP) includes a study of Anktiva™ (N-803) plus Keytruda (pembrolizumab) versus…