Drugs

CDK4/6 Inhibitors Help in Breast Cancer: FDA Study

An FDA pooled study of five registration trials of cyclin-dependent kinases 4/6 (CDK4/6) found that all subgroups of patients with estrogen receptor-positive HER2-negative metastatic breast cancer benefited from the addition of the kinases to endocrine therapy. An ASCOPost online story says the study results were reported by CDER Division of Oncology medical oncologist Jennifer Gao at the 2018 American Society of Clinical Oncology (ASCO) meeting. The FDA results differ from those presented by other researchers at the 2017 European Society for Medical Oncology conference, which said that combination therapy is probably not warranted in all patients.

ASCO says FDA found no particular subsets of patients with greater or lesser benefit from the addition of CDK4/6 inhibitors to endocrine therapy, either in the first-line or second-line setting. “The suggested conclusion is that all patients with hormone receptor-positive, HER2-negative metastatic breast cancer may benefit from this class of agents,” the story says.

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