FDA Authorizes Novocure’s New Device to Prolong Pancreatic Cancer Survival
The U.S. Food and Drug Administration (FDA) has granted approval for Novocure’s innovative wearable device aimed at enhancing survival rates for patients with advanced pancreatic cancer. This device, named Optune Pax, has shown promising results when used alongside standard chemotherapy treatments, specifically gemcitabine and nab-paclitaxel.
How Optune Pax Works
Optune Pax utilizes high-frequency electric fields to combat the aggressive nature of pancreatic cancer. Patients attach adhesive arrays to their skin near the tumor site. These arrays generate electric fields that disrupt cancer cell division, thus inhibiting tumor growth.
Significant Clinical Trial Findings
In a comprehensive Phase 3 clinical trial, patients equipped with Optune Pax exhibited median overall survival of 16.2 months. In contrast, those receiving only chemotherapy had a median survival of 14.16 months. This difference is statistically significant, underscoring the effectiveness of the new device.
- Median survival extension: 2 months
- Median survival for device group: 16.2 months
- Median survival for chemotherapy-only group: 14.16 months
Impact on Patient Pain
The device also significantly alleviated pain associated with pancreatic cancer. The time until pain worsened was 15.2 months for the device group, compared to just 9.1 months for those on chemotherapy alone. This suggests Optune Pax not only prolongs survival but also enhances the quality of life for patients.
Background on Novocure
Founded in 2000 by Prof. Yoram Palti, who was a recipient of the Israel Prize for entrepreneurship, Novocure started as a small Israeli startup. While it has shifted its headquarters to Switzerland, its research and development center remains in Haifa, Israel. Under CEO Frank Leonard, Novocure is publicly traded on Nasdaq and has a market capitalization of approximately $1.2 billion.
Previous Approvals and Future Potential
The technology driving Optune Pax, known as Tumor Treating Fields (TTFields), has also seen past approvals for glioblastoma and mesothelioma. The latest approval for pancreatic cancer marks a significant advancement, as treatment options for this stage of cancer are often limited.
According to Novocure, the introduction of Optune Pax represents the first new treatment modality in decades for patients facing locally advanced pancreatic cancer, emphasizing the need for innovative solutions in this challenging area of oncology.
