Drugs

Adding CDK Inhibitors Helps Some Breast Cancer Treatment: Study

CDER researchers say they have determined that adding a cyclin-dependent kinase (CDK) 4/6 inhibitor to a hormonal agent appears to show a consistent benefit for all subgroups analyzed in a study of hormone receptor-positive, HER2-negative metastatic breast cancer. An agency online Regulatory Science Impact Story says the research involved pooled data from seven breast cancer clinical trials for therapies approved before 1/1/19. The pooled trials covered 4,200 patients, which allowed for a larger patient sample size for each of the subgroups analyzed, compared to the sample size for any single trial alone, the report says.

“The benefit of adding a CDK 4/6 inhibitor to a hormonal agent was consistent across all subgroups,” CDER says, “which provides important information to clinicians and patients for treatment decision-making. This study will also inform the design and analysis of future clinical trials of hormone receptor-positive, HER2-negative metastatic breast cancer.”

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