While stakeholders welcomed the FDA’s recent draft guidance on leveraging prior knowledge, many urged the agency to broaden its recommendations beyond genome editing products. Several also pushed for clarity on how the guidance will connect to other related regulatory concepts, such as the plausible mechanism framework and platform technology designation. Genome editing products at the…
Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the types of scientifically valid prior knowledge sponsors may consider when developing gene therapies that involve genome editing to explicitly apply to other types of cell and gene therapies (CGT). In June, FDA published the…
Investigators from Friends of Cancer Research (Friends) recently published two manuscripts supporting the use of circulating tumor DNA (ctDNA) as an early endpoint for regulatory decision-making. The first article, published by Andrews et al in the Journal of Liquid Biopsy, aggregated data from randomized clinical trials in the ctMoniTR Project to perform a meta-analysis assessing associations between changes…
As countries like China ramp up their drug development, US stakeholders will need to explore how to remain competitive in the cancer therapy landscape. The US has been a leader in drug development for multiple decades, bringing new therapies to patients as quickly as possible.1,2 Recently, though, regulatory leaders abroad, particular in China, have implemented new…
Drug development must convene a forum for candid, cross-sector discussion At the 2026 Annual Meeting of the American Society of Clinical Oncology in Chicago, results from the phase III HARMONi-6 trial were presented at the plenary session and published simultaneously in The Lancet.1 The HARMONi-6 trial tested a novel bispecific antibody that engages PD-1 and VEGF (ivonescimab),…
The U.S. Food and Drug Administration (FDA) recently finalized three guidance documents that aim to make clinical trials for oncology drugs more accessible to patients by encouraging sponsors to reconsider eligibility criteria. Issued by the FDA’s Oncology Center of Excellence, the documents address performance status, washout periods, and concomitant medications and laboratory values. Experts say that the…
City of Hope’s national clinical trials model can activate a study across a network of 40 sites in 4 states within 90 days, according to Edward Kim, MD, MBA. In September 2025, City of Hope launched a national clinical trials model designed to let it open new studies simultaneously across its network rather than site by site,…
FDA’s Oncology Center of Excellence has published three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. Fewer than 5% of cancer patients currently receiving treatment are enrolled in clinical trials even though more than 70% say they are willing to participate, the agency wrote in a press…
New documents targeting performance status, washout periods, and laboratory value thresholds aim to close the gap between patients willing to participate in oncology trials and those who actually enroll. The FDA’s Oncology Center of Excellence (OCE) has issued three final guidance documents intended to expand eligibility criteria for participation in oncology clinical trials, targeting a…
The FDA changed relatively little in finalizing three guidance documents that contain recommendations for constructing cancer trial eligibility criteria involving laboratory values, concomitant treatment and performance status. The concepts they explain may also apply to other clinical areas. Clinical trial representation: A quick background The FDA requires substantial evidence of a drug or biologic product’s…
