Drugs

Comments on Including Older Adults in Cancer Trials

The Alliance for Aging Research says it is encouraged that FDA is continuing to urge industry and other stakeholders to enroll diverse populations in their clinical trials, and especially older adults. Commenting on an agency draft guidance on inclusion of older adults in cancer clinical trials, the alliance says the draft “is another important step in addressing the underrepresentation of older adults in cancer clinical trials. It sends a strong message to oncology development programs that they should be deliberate in their recruitment efforts to enlist a group of older adults that reflects the intended population for the treatment being studied and evaluated.” The group offers detailed comments on early clinical development, clinical trial design and analysis, postmarket data, expanding to all clinical trials, and additional considerations.

In its comment letter, Genentech says it supports FDA efforts to develop guidances and strategies for the inclusion of specific patient subpopulations in clinical trials. “For these strategies to have the most impact,” it says, “we believe that it is essential that they be developed with the goals of both access and research in mind, and that they ensure that trial integrity is maintained for the benefit of all current and future patients.” The firm says its specific comments include recommendations on how the statistical considerations described in the draft guidance can be improved. It also asks FDA to provide further guidance on ways in which alternative data sources and methodologies can be used to supplement the limited clinical data that may be obtained from specific subpopulations to inform the benefit/risk profile and support labeling recommendations and potential efficacy claims for these patients.

Pfizer says expanding clinical trial inclusion criteria should not slow development and it encourages FDA to apply additional flexible and practical innovative approaches, including using model informed drug development and real-world data approaches to include or obtain meaningful data from older patients without delaying the rest of the development program so that new medicines can reach patients as soon as possible.

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