Drugs

2 Approvals Encourage Precision Medicine: Woodcock

CDER director Janet Woodcock says that two recent agency drug approvals “point to an encouraging future for precision medicine — an approach for disease treatment that tailors medical therapies, including medications, to the needs of individual patients.” Writing in an FDA Voice blog post, Woodcock cited the approvals of Vertex’ Kalydeco (ivacaftor), a cystic fibrosis drug, and Merck’s Keytruda (pembrolizumab), a cancer drug.

“FDA has approved many more advances in precision medicines, also called ‘targeted therapies,’” Woodcock writes. “In the past three years alone, CDER has approved more than 25 new drugs that benefit patients with specific genetic characteristics. And we have approved many more new uses — also based on specific genetic characteristics — for drugs already on the market.”

The post says that while precision medicine holds great promise, scientific advances in the use and development of biomarkers will be needed to continue developing targeted therapies. “FDA continues to encourage drug developers to use strategies based on biomarkers,” Woodcock says. “One way we do that is by ensuring that a given biomarker is really able to single out those patients who are likely to respond to a specific drug. Another way is using biomarkers to identify people whose disease is progressing rapidly. Beyond working on biomarkers for individual products, FDA also works with stakeholders and scientific consortia in qualifying biomarkers that can be used in the development of many drugs. Once qualified, these biomarkers may be used in the specified manner by any drug sponsor.”

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