Drugs

Laboratory Value-Based Eligibility Criteria in Cancer Trials Guidance

A final FDA guidance is urging sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to patient participation while maintaining appropriate safety protections. The agency said overly restrictive laboratory requirements can limit enrollment, reduce trial diversity, and make study results less representative of the patients who will ultimately receive approved therapies.

The guidance, “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” recommends that laboratory-based exclusion criteria be used only when scientifically justified by a drug's safety profile, mechanism of action, or expected toxicity. FDA also advises sponsors to reassess eligibility criteria as clinical data accumulate, particularly when moving from early- to late-stage trials, and to eliminate restrictions that are no longer warranted.

The agency notes that unnecessarily strict requirements for kidney, liver, and blood function have historically excluded many patients — including older adults and individuals with naturally occurring laboratory differences across racial and ethnic populations — from participating in cancer studies. FDA said broader eligibility criteria can improve the generalizability of clinical trial results and provide a more complete understanding of a drug's benefit-risk profile in real-world patients.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome