This section highlights FDA-related milestones and regulatory updates for drugs developed by NovoCure (NVCR).
Over the past two years, NovoCure has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Optune and Tumor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Optune Lua - FDA Regulatory Timeline and Events
Optune Lua is a drug developed by NovoCure for the following indication: For the Treatment of Metastatic Non-Small Cell Lung Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Optune Lua
- Announced Date:
- April 22, 2025
- Indication:
- For the Treatment of Metastatic Non-Small Cell Lung Cancer
Announcement
Novocure announced that Optune Lua® has received a CE (Conformité Européenne)Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.
AI Summary
Novocure announced that its wearable device, Optune Lua®, has received the CE Mark for treating adult patients with metastatic non‐small cell lung cancer (NSCLC) who have progressed on or after a platinum-based regimen. This approval means Optune Lua can now be used alongside immune checkpoint inhibitors or the chemotherapy drug docetaxel. The decision was supported by the Phase 3 LUNAR trial, which was the first in over eight years to show a significant improvement in overall survival for this group of patients, extending median survival by about 3.3 months. Optune Lua works by delivering Tumor Treating Fields (TTFields), which use electric fields to disrupt cancer cell division while causing minimal harm to healthy cells. This new option offers hope for patients with aggressive lung cancer by providing an effective treatment with a favorable safety profile.
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Tumor Treating Fields - PANOVA-3 - FDA Regulatory Timeline and Events
Tumor Treating Fields - PANOVA-3 is a drug developed by NovoCure for the following indication: Locally advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tumor Treating Fields - PANOVA-3
- Announced Date:
- July 1, 2025
- Indication:
- Locally advanced pancreatic cancer
Announcement
Novocure announced that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer.
AI Summary
Novocure announced that it will present the final secondary endpoint results from its Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for patients with unresectable, locally advanced pancreatic cancer. The data will be shared at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 in Barcelona. These final results focus on quality-of-life outcomes, including improvements in pain control and a significant delay in the time patients needed to start opioid pain medications. The trial compared TTFields used together with gemcitabine and nab-paclitaxel against chemotherapy alone. Earlier findings from PANOVA-3 already showed a survival benefit, and now these additional results support that combining TTFields with chemotherapy may help slow pain progression and preserve quality of life, making it a promising new therapy option for this challenging form of pancreatic cancer.
Read Announcement- Drug:
- Tumor Treating Fields - PANOVA-3
- Announced Date:
- May 31, 2025
- Indication:
- Locally advanced pancreatic cancer
Announcement
Novocure announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology.
AI Summary
Novocure announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The trial evaluated TTFields therapy used alongside gemcitabine and nab-paclitaxel for patients with unresectable, locally advanced pancreatic adenocarcinoma. Results showed that the combination provided a statistically significant improvement in overall survival along with a prolonged period of pain-free survival and better quality of life, offering additional hope for patients facing this challenging diagnosis. In addition to the ASCO presentation, the detailed findings will be published simultaneously in the Journal of Clinical Oncology, providing clinicians with further insights into this innovative treatment approach.
Read Announcement- Drug:
- Tumor Treating Fields - PANOVA-3
- Announced Date:
- December 2, 2024
- Indication:
- Locally advanced pancreatic cancer
Announcement
Novocure announced today that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control.
AI Summary
Novocure announced that the pivotal Phase 3 PANOVA-3 trial met its primary endpoint by showing a statistically significant improvement in median overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma. In this study, patients treated with Tumor Treating Fields (TTFields) therapy alongside gemcitabine and nab-paclitaxel experienced an improved median overall survival of 16.20 months compared to 14.16 months for those treated with chemotherapy alone. This 2.0-month improvement highlights a promising benefit for a patient group that has very few effective treatment options.
The encouraging trial results are driving plans for regulatory filings in key markets, including the U.S., EU, Japan, and China. Novocure and its partner Zai Lab are preparing to share the full trial data at an upcoming medical congress, marking a significant milestone in the fight against pancreatic cancer.
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