Drugs

Cancer White Paper on Dosage Optimization

A Friends of Cancer Research (Friends) white paper proposes a fit-for-purpose approach to support administered activity escalation and dosage optimization in radiotherapeutic therapy (RPT) development. Friends says its approach is based on these core principles:

use escalation to generate RPT-specific evidence;
anchor decisions to the totality of evidence; and
design evidence-generation strategies that are practical and patient-centered.

The paper lists these near-term recommendations and future directions:

establish shared principles for administered activity escalation in RPT development;
advance totality-of-evidence decision-making;
harmonize prospective evidence generation; and
support iterative refinement of RPT-specific dosage optimization frameworks.

“Together,” the Friends paper says, “these steps can help shift RPT development from inappropriate reliance on historical external beam radiation therapy-derived reference points toward evidence-based approaches tailored to the characteristics of each therapy. Prospectively generating and integrating RPT-specific evidence can support more informed administered activity escalation decisions, strengthen the basis for dosage selection, and enable continued refinement of dosage optimization strategies as evidence accumulates across development. Over time, the approach can help establish a stronger empirical foundation for RPT dosage optimization and better align safety, therapeutic activity, and patient benefits.”

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