Drugs

In Vitro Companion Device Labeling Guidance

FDA has issued a draft guidance, In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products, to describe considerations for development and labeling of companion diagnostic devices to support the indicated use of multiple drug or biologic oncology products when appropriate. The document includes factors for consideration when broader labeling (labeling that is expanded) of a companion diagnostic would be appropriate.

The agency says the draft expands on existing policy surrounding broader labeling that notes that in some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group or class of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group or class of therapeutic products rather than specific products.

In a statement announcing the guidance, FDA commissioner Scott Gottlieb says that when finalized, the policy reflected in the guidance “will make it easier for providers to use the same test in helping guide the use of a class of oncology therapeutic products, rather than one specific oncology therapeutic product within that class. The guidance will help guide test developers who could use the data generated from the study of an approved or cleared diagnostic test that’s evaluated in relation to just one oncology therapeutic product in a class of molecularly-targeted oncology therapeutic products to then extrapolate the use of that same approved or cleared diagnostic test to the entire oncology therapeutic product class.”

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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