Drugs

Restrict Some Lung Cancer Drugs: Petition

Ochsner MD Anderson Cancer Center system medical director of precision medicine Marc Matrana is calling on FDA to require a labeling change for immunotherapies used to treat non-small cell lung cancer involving a Limitation of Use to exclude patients with ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (“ROS1”) and Rearranged during Transfection, Tyrosine Kinase Inhibitors (“RET”) rearrangements (or gene fusions) from the indicated patient populations to redirect such patients to safer and more effective targeted Tyrosine Kinase Inhibitors. The 6/11 petition says prescribing information for the drugs should reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first-line option.

“Current immunotherapy labeling does not reflect the emerging evidence showing reduced effectiveness and increased toxicity in ROS1- and RET-positive patients,” the petition says. “By failing to warn clinicians that immune checkpoint inhibitors are inappropriate as first-line therapy for these populations, current labeling creates a reasonable likelihood of clinicians initiating a therapy that (1) provides minimal chance of benefit, (2) delays access to highly effective tyrosine kinase inhibitors, and (3) increases risk of hospitalization due to rapid progression or immune-mediated toxicity.”

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