Drugs

FDA Posts 1st Clinical Study Report in Transparency Pilot

A new FDA drug approval transparency pilot program has released the first Clinical Study Report (CSR) which provides more background on why the agency recently approved Janssen Biotech’s Erleada (apalutamide), the first treatment for non-metastatic, castration-resistant prostate cancer. The drug was approved last month and it was the first approval to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment (see earlier story).

Announced earlier this year, the pilot will post the CSRs from up to 9 drug approvals from participating sponsors. In a 3/19 blog post, CDER director Janet Woodcock said she believes the pilot’s “CSR information, together with the FDA review, label, and other supporting documents, will facilitate a deeper understanding of how we reached our approval decision. As an added benefit, our pilot program can help with global alignment, as our counterparts at the European Medicines Agency are similarly working to make information about their approvals more accessible and easier to understand.”

Woodcock said that while current approval documents posted online include a significant amount of information pulled in from sponsors’ applications, they do not provide a complete summary of the results of any given study. “By providing the CSRs we hope to:

Enhance the accuracy of information used in scientific publications;
Increase stakeholders’ understanding of the basis for FDA’s approval decisions; and,
Inform physicians and other healthcare providers about the detailed results that regulatory decisions were based on.”

The CSR package for Janssen Biotech’s Erleada can be viewed by clicking the links below:

Clinical Study Report (body) (PDF)
Protocol (PDF)
Statistical Analysis Plan (PDF)

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