Devices

FDA OKs Novocure’s Optune Pax for Advanced Pancreatic Cancer

FDA has approved Novocure’s Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer, marking the first new FDA-approved treatment for this setting in nearly three decades.

The approval is based on data from the Phase 3 PANOVA-3 trial, which demonstrated a statistically significant improvement in overall survival when the wearable device was added to standard chemotherapy, along with a significant delay in pain progression, according to the company. The device delivers Tumor Treating Fields (TTFields), alternating electric fields designed to disrupt cancer cell division. The therapy is administered noninvasively through wearable arrays placed on the skin and represents a biophysical approach distinct from traditional systemic treatments, it says.

In PANOVA-3, median overall survival was 16.2 months in the Optune Pax plus chemotherapy arm, compared with 14.2 months for chemotherapy alone. a 2.0-month improvement, the company says. In the modified per-protocol population, median overall survival reached 18.3 months with Optune Pax versus 15.1 months with chemotherapy alone. The device also improved key secondary endpoints. One-year survival in the intent-to-treat population was 68.1% with Optune Pax, compared with 60.2% for chemotherapy alone. In the modified per-protocol group, one-year survival was 75.2% versus 65.9%, respectively.

Pain control — a major clinical challenge in pancreatic cancer — also improved. Median time to pain progression was 15.2 months in the Optune Pax arm, compared with 9.1 months in the chemotherapy-only group, the company says. Quality-of-life analyses showed longer deterioration-free survival in global health status, pain, pancreatic pain and several digestive symptoms, it adds.

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