Drugs

FDA Partnering with CancerLinQ on Treatment Use

FDA says it has entered into a long-term partnership with CancerLinQ, the American Society of Clinical Oncology’s big data initiative, to use cancer patient information and big data analytics to examine the real-world use of emerging and newly-approved cancer therapies. A statement issued by CancerLinQ says its real-world data “will be used to grow the knowledge base about patterns of care across all cancer types and therapies, accelerate development of novel insights that might otherwise be challenging to obtain through standard research initiatives and data collection means, as well as potentially inform FDA regulatory strategy and decision-making processes.”

The statement says that an initial FDA and CancerLinQ project focuses on treatments for advanced melanoma and aims to characterize the real-world experience of patients, inform the clinical use of currently approved therapies, and potentially inform future FDA regulatory review of targeted drugs and immunotherapies.

“CancerLinQ and FDA investigators will explore a variety of issues related to the use of newly approved therapies, including the optimal sequence of treatments, the impact that other health problems have on treatment tolerability and cancer outcomes, and the experience with immunotherapy combination versus single agents,” the statement says. “CancerLinQ and FDA will share their findings with the cancer community to help guide the use of these treatments and inform the development of future clinical trials. FDA may also apply the findings to future drug reviews of labeling refinements.”

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