Drugs

Draft Guide on Setting Endotoxin Limits for Cancer Therapies

FDA has posted a draft guidance entitled “Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.” The document describes FDA’s recommendations for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two or more investigational drugs. It is limited to anticancer drugs, including combination products administered parenterally (except for intraocular administration) to treat serious and life-threatening cancers based on histology or stage of disease. FDA says the guidance does not apply to developing drugs for adjuvant or neoadjuvant treatment or for cancer subtypes that can be cured or where prolonged survival can be achieved with available therapy.

According to the guidance, FDA’s recommendations are consistent with abbreviated product testing for feasibility clinical trials of monoclonal antibodies in patients with serious or immediately life-threatening conditions for which no effective alternative treatment exists. “In this guidance,” it says, “FDA recommends a risk-based approach, weighing the potential risks of possible exposure to increased levels of endotoxin across all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening cancers.”

The guidance also cites compendial recommendations for threshold pyrogenic doses of endotoxins for injectable products, which are based upon the results of human and animal studies demonstrating the deleterious effects of bacterial endotoxins administration. United States Pharmacopeia General 114 Chapter 151 Pyrogen Test also provides a test method and acceptance criteria for the absence of pyrogens by measuring febrile reactions to injectable products, the guidance notes. FDA says it expects that IND sponsors will justify the proposed endotoxin acceptance criteria for each investigational therapeutic biologic, drug, or combination therapy “based on manufacturing experience and established control strategies, such as careful selection of ancillary materials, aseptic processing, and the use of closed systems.”

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