Drugs

FDA Cancer Biomarker Pilot

FDA has launched a voluntary pilot program to help cut risks in using laboratory-developed tests (LDTs) to identify cancer biomarkers. An online statement says the agency has become increasingly concerned that some tests made by laboratories and not authorized by FDA may not provide accurate and reliable test results or perform as well as authorized tests. The program is announced in a guidance.

“This may negatively impact treatment decisions,” the statement says. “This pilot program is one step that may be helpful in reducing the risk of using LDTs for oncology drug treatment decisions while we continue to work on a broader approach for LDTs, including moving forward with rulemaking.”

Under the pilot program, FDA will ask drug manufacturers for performance information for the tests used to enroll patients into clinical trials that support drug approval. “Based on an assessment of that information,” the statement says, “FDA will post to the FDA Web site the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment. This transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and approved care for patients with cancer.”

The initial phase of the pilot is expected to last up to one year, FDA says, during which the agency will evaluate no more than nine drug sponsors for possible acceptance into the program.

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