Drugs

Surrogate Marker Treatment Effects Can Vary: Study

Treatment effects from pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease are often larger than the treatment effects observed among post-approval trials using surrogate markers as trial endpoints, specifically for non-continuous surrogate markers, according to a study published online in BMC Medicine. Yale University researchers say that new proposals for increased reliance on smaller and shorter trials with surrogate markers carry the risk of demonstrating larger, and potentially exaggerated, treatment effects, which may ultimately lack reproducibility or generalizability.

“Policymakers, doctors, and patients should interpret treatment effects based on surrogate markers of disease as primary endpoints with caution, and in the absence of clinical outcomes, regulators and payers should focus on those surrogate markers that have been validated,” the researchers say.

The study found that the treatment effects based on non-continuous surrogate markers in pivotal trials are larger than, and may overestimate, the treatment effects based on the exact same non-continuous surrogate markers when used in post-approval trials. It also found that many post-approval drug trials are not directly comparable to previously published pivotal trials, particularly with respect to endpoint selection.

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