European approval covers 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.
Baar, Switzerland-based Novocure develops the Optune platform for delivering tumor treating fields (TTFields) to treat cancer. Its Optune Pax portable, therapeutic device, delivers TTFields non-invasively through wearable arrays. The alternating electrical fields target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival. This leads to cell death without significantly affecting healthy cells.
To support its CE mark submission, Novocure used findings from the PANOVA-3 study. In findings shared just over a year ago, the company said the trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) with TTFields.
Novocure won FDA approval for Optune Pax concomitant with gemcitabine and nab-paclitaxel for advanced pancreatic cancer in February. The platform also has approval for non-small cell lung cancer.
With CE mark secured, the company plans to launch Optune Pax in Germany in the coming weeks. It also has the system under evaluation in the PANOVA-4 study for metastatic pancreatic cancer.
Commentary from Novocure officials and clinicians
Anne Calixte de Lembeye, SVP, EMEA and Canada, Novocure, said:
“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. 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 benefit from treatment.”
Dr. Teresa Macarulla, head of the Dept. of Medical Oncology at Hospital Clínic Barcelona, said:
“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. 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.”
