Devices

Novocure Reports Favorable Long-term Data with Optune System

Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confirms superior progression free and overall survival in newly diagnosed glioblastoma multiforme (GBM) patients. “The long-term analysis shows survival rates were significantly higher four years from randomization in patients receiving Optune with temozolomide compared to patients receiving temozolomide alone,” the company says.

In the U.S., Optune is approved for treating recurrent GBM following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted, the company says.

In July, FDA approved PMA supplement for its second generation Optune system that features new smaller, lighter Tumor Treating Fields (TTFields) that are less than half the weight and half the size of the generator in the first Optune system, according to the company. Including its battery, the second generation Optune system weighs 2.7 pounds, compared to six pounds for the earlier model. “Novocure reduced the size and weight of Optune by utilizing novel digital signal generation technology,” the company says. “Additional improvements include: easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a ‘No-Stop Swap’ feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.”

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