Drugs

FDA Working on Patient-Friendly Cancer Terms

Five FDAers working in various CDER positions involving cancer drugs and treatment say the agency is working to help resolve a problem that occurs when patients and their families don’t understand information they are given about a cancer diagnosis and treatment options. Writing in an open-source article in The Oncologist, the FDAers say a “complete understanding of the risks and benefits of cancer therapies would allow patients and their families to make informed choices in their treatments. It is also important to be mindful of the patient as an individual and consider what specific terms need to be used when speaking with patients, as well as how and when to disseminate literature to patients.”

Examples of oncology terminology that may be unclear or not explained to patients, the authors say, are progression-free survival, overall survival, disease-free survival, and overall response rate. They say such terms are ubiquitous in cancer drug development, but are nuanced and can be associated with complicated clinical trial designs.

The first step in developing more explanatory materials, they say, is to work with patients and advocacy groups toward a better understanding of the problem. Definitions of common terms can then be generated in an iterative dialog between patients, healthcare providers, and drug development scientists. “Once an agreed-upon set of patient-friendly definitions is generated by various stakeholders,” the article says, “these definitions can be communicated in multiple ways, including Web resources, provider education (including pharmacists and clinicians), and patient advocacy groups. The use of multiple sources of information for patients may help to mitigate the challenge of increasing time pressures at the point of care.”

The FDAers say the agency has generated a draft patient-friendly definition of progression-free survival as a starting point for further work.

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