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
gemcitabine, Tumor, Optune, and Tumor. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Gemcitabine and nab-paclitaxel (GnP) FDA Regulatory Events
Gemcitabine and nab-paclitaxel (GnP) is a drug developed by NovoCure for the following indication: first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone.
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:
- gemcitabine and nab-paclitaxel (GnP)
- Announced Date:
- October 15, 2025
- Indication:
- first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone.
Announcement
Novocure announced that it will present data at two upcoming oncology congresses, the 2025 European Association of Neuro-Oncology (EANO) Meeting, being held October 16-19 in Prague, Czech Republic, and the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany.
AI Summary
Novocure announced it will share new Tumor Treating Fields (TTFields) data at two European conferences in October 2025. The first session is at the European Association of Neuro-Oncology (EANO) Meeting, October 16–19 in Prague. Novocure will present preclinical findings showing that short exposure to TTFields makes glioblastoma cells more sensitive to radiation by lowering their DNA repair activity. This data appears as Poster P18.24.B, presented by Anat Klein-Goldberg.
The second session is at the European Society for Medical Oncology (ESMO) Congress, October 17–21 in Berlin. Novocure will share a post-hoc analysis from its Phase 3 PANOVA-3 trial, comparing TTFields plus gemcitabine and nab-paclitaxel (GnP) to GnP alone in unresectable pancreatic cancer. The analysis evaluates effectiveness based on daily device use and CA 19-9 levels. These results are featured as Poster 2235P, presented by Dr. Hani Babiker.
Read Announcement
Tumor Treating Fields - METIS FDA Regulatory Events
Tumor Treating Fields - METIS is a drug developed by NovoCure for the following indication: Brain metastases.
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 - METIS
- Announced Date:
- September 29, 2025
- Indication:
- Brain metastases
Announcement
Novocure nnounced that final results from the Phase 3 METIS trial of Tumor Treating Fields (TTFields) therapy for brain metastases from non-small cell lung cancer (NSCLC) will be presented today at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting taking place September 27 – October 1 in San Francisco and simultaneously published in the International Journal of Radiation Oncology Biology and Physics (Red Journal).
AI Summary
Novocure announced that final results from the Phase 3 METIS trial of Tumor Treating Fields (TTFields) therapy for brain metastases from non-small cell lung cancer (NSCLC) will be presented today at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting in San Francisco and simultaneously published in the International Journal of Radiation Oncology Biology and Physics. The trial met its primary endpoint by demonstrating a statistically significant delay in intracranial progression for patients receiving TTFields plus best supportive care following stereotactic radiosurgery.
The METIS trial enrolled 298 adult patients with one to ten brain metastases from NSCLC who were randomized to receive TTFields plus best supportive care or best supportive care alone after radiosurgery. Patients treated with TTFields had a 28% lower risk of intracranial progression and saw median progression-free time double from 7.5 to 15.0 months compared to supportive care alone.
TTFields therapy was well tolerated, with no negative impact on patients’ quality of life or neurocognitive function. Novocure’s leadership describes these findings as a pivotal step toward a new, durable treatment option. Results are publicly available in the Red Journal and were shared at ASTRO’s plenary session today.
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Optune Lua FDA Regulatory 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:
- September 15, 2025
- Indication:
- For the Treatment of Metastatic Non-Small Cell Lung Cancer
Announcement
Novocure announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.
AI Summary
Novocure announced that Japan’s Ministry of Health, Labour and Welfare approved Optune Lua® for use alongside PD-1/PD-L1 inhibitors in adults with unresectable advanced or recurrent non-small cell lung cancer who have progressed after platinum-based chemotherapy. This marks the first approval in Japan for combining Tumor Treating Fields (TTFields) therapy with immune checkpoint inhibitors for this patient group.
The approval is based on the Phase 3 LUNAR trial, which showed a statistically significant 3.3-month improvement in median overall survival for patients treated with Optune Lua plus a PD-1/PD-L1 inhibitor or docetaxel (13.2 vs. 9.9 months). In a key subgroup, those receiving Optune Lua with a PD-1/PD-L1 inhibitor saw an 8.2-month extension (19.0 vs. 10.8 months; P=0.02).
Optune Lua is a portable device that delivers alternating electric fields to disrupt cancer cell division. Most side effects were mild skin reactions under the arrays, with no severe (Grade 4–5) toxicities reported.
Read Announcement- 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:
- August 20, 2025
- Indication:
- Locally advanced pancreatic cancer
Announcement
Novocure announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer.
AI Summary
Novocure submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its Tumor Treating Fields (TTFields) therapy targeting locally advanced pancreatic cancer. The application relies on the international PANOVA-3 trial, where patients received TTFields with gemcitabine and nab-paclitaxel versus chemotherapy alone. The trial met its primary goal, showing a significant improvement in median overall survival for the TTFields group. Results were featured at the 2025 American Society of Clinical Oncology meeting and published in the Journal of Clinical Oncology.
The PMA was filed as a supplement to Optune Lua®, now approved for non-small cell lung cancer. It is expected to become a separate pancreatic cancer approval. Novocure expects an FDA decision in the second half of 2026. CEO Ashley Cordova said this step highlights the team’s commitment to offering patients a new treatment option quickly.
Read Announcement- 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.
Read Announcement
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