In The News

August 14, 2026

The Cancer Letter — The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why

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),…

August 13, 2026

Oncology News Central — FDA Moves to Broaden Eligibility for Oncology Clinical Trials

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…

August 10, 2026

Cancer Network — How Is City of Hope Widening National Clinical Trial Access for Oncology?

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,…

July 31, 2026

The Cancer Letter — FDA’s OCE publishes three final guidances to increase clinical trial enrollment

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…

July 29, 2026

Applied Clinical Trials — FDA Finalizes Three Guidances to Broaden Cancer Clinical Trial Eligibility

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…

July 28, 2026

AgencyIQ — FDA finalizes guidances on cancer trial eligibility criteria

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…

July 28, 2026

POLITICO — FDA panel to consider previously spurned drugs

A RARE REDO — An FDA advisory committee will hold two days of meetings this week to review applications for novel therapies disfavored by political appointees who have since left the agency. The Cellular, Tissue and Gene Therapy Advisory Committee will review Capricor’s deramiocel to treat heart issues in Duchenne muscular dystrophy patients on Wednesday. Thursday…

July 28, 2026

The ASCO Post — FDA Releases Final Guidances to Expand Participation in Cancer Clinical Trials

The FDA’s Oncology Center of Excellence announced three final guidance documents intended to broaden eligibility criteria for participation in clinical trials of oncology drugs. Fewer than 5% of patients with cancer currently receiving treatment are enrolled in clinical trials—even though more than 70% say they are willing to participate. The guidance documents address one reason for low participation: stringent…

July 27, 2026

RAPS: Regulatory Focus — FDA finalizes three guidances to broaden cancer clinical trial eligibility

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods. Fewer than 5% of cancer patients currently undergoing treatment are enrolled in…

July 27, 2026

Pink Sheet — Beyond Operation TrialBlazer: Congress Sounds Ready To Act On IND Pathways

Legislators appears eager to build on the US Food and Drug Administration’s plans to expedite IND reviews in the upcoming user fee reauthorization cycle. During a July 15 hearing on the FDA’s role in maintaining US leadership in biomedical innovation, House Energy and Commerce Health Subcommittee Chair Morgan Griffith, R-VA, discussed the importance of reforms to the…

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