Drugs

Guide to Characterize Combination Cancer Drugs

FDA has published a draft guidance, Development of Cancer Drugs for Use in Novel Combination—Determining the Contribution of the Individual Drugs’ Effects, with recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in treating cancer. The document says the guidance is intended for sponsors developing drugs for use in combination to treat cancer.

The guidance reflects FDA’s current thinking about the use of clinical data to demonstrate the contribution of effect for these types of oncology novel combinations:

two or more investigational drugs that have not been previously approved by FDA for any indication;
an investigational drug with a drug approved for a different indication; and
two or more drugs approved for different indications.

The guidance does not address the contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purpose of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indications. It also does not address safety or dosing considerations when designing trials to study two or more drugs when used in combination. Finally, FDA says, it does not address the evaluation of safety data to support the benefit/risk of two or more drugs when used in combination.

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