Drugs

Draft Guide on Real-time Oncology Reviews

FDA has made available a draft guidance entitled “Real-Time Oncology Review (RTOR).” The review program was rolled out 2/2018 to promote earlier submission of topline results (i.e., efficacy and safety results from clinical studies before the study report is completed) and datasets, after database lock, to support an earlier review start.

FDA says the program differs from a rolling review by allowing components of individual modules (e.g., parts of the clinical module, etc.) to be submitted at separate times. A rolling review generally requires complete modules (e.g., the complete clinical module) to be submitted prior to a complete application submission. “The intent of RTOR is to provide FDA reviewers earlier access to data, to identify data quality and potential review issues, and potentially provide early feedback to the applicant, which can allow for a more streamlined and efficient review process,” the guidance says.

FDA says that to be considered for RTOR, submissions should demonstrate the following:

Drug is likely to demonstrate substantial improvement over available therapy
Straightforward study designs as determined by the review division and the Oncology Center of Excellence (OCE)
Easily interpreted clinical trial endpoints (e.g., overall survival, response rates), as determined by the review division and OCE

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