Drugs

FDA Oncology Center of Excellence Site-Agnostic Approval

FDA scientists working in the agency’s Oncology Center of Excellence (OCE) describe the Center’s role in the 5/2017 approval of a cancer treatment based on a biomarker without regard to the tumor’s site. The Experimental Biology and Medicine article describes the accelerated approval given to pembrolizumab for patients with solid tumors that have the microsatellite instability-high or mismatch repair deficient biomarker.

“As precision medicine continues to advance,” the report says, “therapeutic targets are evolving from tissue- or organ-based to gene- or pathway-based. FDA approvals are likely to describe increasingly the use of diagnostic tests to identify patients whose cancers harbor the targeted abnormalities and that may be required (companion diagnostics) for the safe and effective use of these drugs or suggested (complementary diagnostics) to provide physicians and patients with potentially useful information.”

The authors say OCE remains optimistic about the outlook for the future of oncology drug development. A number of initiatives are underway, they say, to improve greater patient access to trials, generalizability of trial data, and learning from electronic medical records and patient-reported outcomes. “We believe the OCE’s strong emphasis on excellence in regulatory science will ensure the rapid development of highly effective and less toxic therapies for patients with cancer,” they conclude.

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