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Novocure’s Optune Pax® Receives CE Mark for the Treatment of Locally Advanced Pancreatic Cancer
Novocure’s Optune Pax® Receives CE Mark for the Treatment of Locally Advanced Pancreatic
About this update from Novocure Limited
Novocure (NASDAQ: NVCR) announced today that Optune Pax® has received CE (Conformité Européenne) Mark for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations. “Pancreatic cancer is often diagnosed in late stages when tumors are more difficult to treat. As a result, treatment options have limited effect and survival rates have remained low for decades. However, in the Phase 3 PANOVA-3 trial for Optune Pax, a statistically significant improvement in overall survival was observed in patients who were at an advanced stage of disease,” said Teresa Macarulla, MD, PhD, Head of the Department of Medical Oncology at Hospital Clínic Barcelona. “In addition, Optune Pax was also shown to delay pain progression, a debilitating symptom of pancreatic cancer. This is a promising treatment for patients who have an urgent need for new options.” Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells. The CE Mark for Optune Pax for locally advanced pancreatic cancer is supported by data from the Phase 3 PANOVA-3 clinical trial, which met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax and gem/nab-pac, compared to those patients who received gem/nab-pac alone, while also significantly extending time to pain progression, a key secondary endpoint. Because the use of gemcitabine and nab-paclitaxel may vary by market, the approved CE Mark intended purpose for Optune Pax includes a reference to guideline recommendations to account for these local differences. “The CE Mark designation is a critical milestone in our efforts to bring Optune Pax to people living with locally advanced pancreatic cancer, a disease in need of new treatment options,” said Anne Calixte de Lembeye, Senior Vice President, EMEA and Canada, Novocure. “We are proud of this achievement and are committed to working with national agencies to secure access to Optune Pax for patients with pancreatic cancer who may ben...