Devices

FDA Breakthrough Device Designation for Novocure System

FDA has granted breakthrough device designation to the Novocure Novo TTF-200T system, a tumor treating fields (TTFields) delivery system intended for use with Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) for the first-line treatment of patients with unresectable or metastatic liver cancer. The company says the designation was based in part on clinical data from its phase 2 pilot HEPANOVA trial testing the safety and efficacy of TTFields together with sorafenib (Bayer’s Nexavar) for the treatment of advanced liver cancer.

In granting the designation, the company says, FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology that has the potential to be a more effective treatment.

TTFields are described as electrical fields that disrupt cancer cell division. They are intended principally for use with other standard-of-care cancer treatments. Novocure says TTFields have exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

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