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, gem/nab-pac, Tumor, gemcitabine, Tumor, 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.
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:
- November 9, 2026
- Indication:
- For the Treatment of Metastatic Non-Small Cell Lung Cancer
Announcement
Novocure announced today that it has received a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) in response to its Premarket Approval (PMA) application for Optune Mya® for the treatment of adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
Read Announcement- Drug:
- Optune Lua
- Announced Date:
- March 2, 2026
- Indication:
- For the Treatment of Metastatic Non-Small Cell Lung Cancer
Announcement
Novocure announced today that Japan's Ministry of Health, Labour and Welfare approved reimbursement for Optune Lua® through the country's National Health Insurance coverage.
AI Summary
Novocure announced that Japan’s Ministry of Health, Labour and Welfare has approved reimbursement for Optune Lua® under the country’s National Health Insurance. This decision means eligible patients can receive coverage for the therapy, reducing direct cost barriers and supporting wider clinical use across Japan.
Optune Lua is a wearable, portable device that delivers Tumor Treating Fields (TTFields) through non-invasive arrays placed on the body. TTFields are alternating electric fields that disrupt dividing cancer cells and can lead to cancer cell death. In Japan, Optune Lua is approved for use with PD-1/PD-L1 immune checkpoint inhibitors in adults with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.
Qualified health centers will provide the therapy to eligible patients. NSCLC accounts for about 85% of lung cancers, and roughly 100,000 people are diagnosed with NSCLC annually in Japan, underscoring the potential impact of this coverage decision.
Read Announcement- 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.
Read Announcement
Gem/nab-pac FDA Regulatory Events
Gem/nab-pac is a drug developed by NovoCure for the following indication: Metastatic 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:
- gem/nab-pac
- Announced Date:
- June 30, 2026
- Indication:
- Metastatic Pancreatic Cancer
Announcement
Novocure announced 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.
AI Summary
Novocure announced that Optune Pax has received the CE Mark in Europe for treating adults with locally advanced pancreatic cancer of exocrine origin, when used with gemcitabine and nab-paclitaxel as recommended by treatment guidelines. The approval is based on the Phase 3 PANOVA-3 trial, which showed that adding Optune Pax to gem/nab-pac helped patients live longer than chemotherapy alone. The device also significantly delayed pain progression, which may help patients keep a better quality of life during treatment.
Optune Pax is a wearable, portable medical device that sends Tumor Treating Fields, or TTFields, through the skin. These alternating electric fields are designed to disrupt cancer cell division and survival while limiting damage to healthy cells. In PANOVA-3, patients using Optune Pax plus gem/nab-pac had a median time to pain progression of 15.2 months, compared with 9.1 months for chemotherapy alone. Novocure said it plans to launch Optune Pax in Germany soon.
Read Announcement- Drug:
- gem/nab-pac
- Announced Date:
- March 26, 2026
- Indication:
- Metastatic Pancreatic Cancer
Announcement
Novocure announced positive results today from the Phase 2 PANOVA-4 trial of Tumor Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq®),gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).
AI Summary
Novocure announced positive Phase 2 PANOVA-4 results testing Tumor Treating Fields (TTFields) given with atezolizumab (Tecentriq®) plus gemcitabine and nab-paclitaxel as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial measured disease control rate (DCR) as the share of patients with stable disease for at least 16 weeks or a confirmed partial or complete response by RECIST v1.1. Novocure reported encouraging outcomes overall and plans to present additional details at a future scientific forum.
Median TTFields therapy lasted 25.6 weeks and patients received a median of six cycles of systemic therapy (atezolizumab with gem/nab-pac). TTFields were well tolerated and device-related safety matched prior studies. The results support further evaluation of TTFields combined with immunotherapy and chemotherapy for first-line treatment of mPDAC.
Read Announcement
Tumor Treating Fields Therapy FDA Regulatory Events
Tumor Treating Fields Therapy is a drug developed by NovoCure for the following indication: Antimitotic cancer treatment for glioblastoma.
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 Therapy
- Announced Date:
- June 18, 2026
- Indication:
- Antimitotic cancer treatment for glioblastoma
Announcement
Novocure announced topline results today from its Phase 3 TRIDENT trial, which evaluated the initiation of Tumor Treating Fields (TTFields) therapy for newly diagnosed glioblastoma (GBM) at the start of chemoradiation (Early Start Arm) compared to initiating TTFields therapy during the subsequent maintenance phase of treatment (Maintenance Start Arm).
AI Summary
Novocure announced topline results from its Phase 3 TRIDENT trial in newly diagnosed glioblastoma. The study tested whether starting Tumor Treating Fields (TTFields) therapy at the beginning of chemoradiation would improve survival compared with starting TTFields later during the maintenance phase.
The trial did not meet its main goal. Patients who started TTFields early had a median overall survival of 17.7 months, compared with 17.5 months for those who started during maintenance. This difference was not statistically significant. Still, the company said survival benefits were durable in both groups over time.
TTFields therapy was generally well tolerated, and no new safety problems were seen. Novocure said early use of the therapy was feasible. The results have been accepted for presentation at the ASTRO 2026 Annual Meeting.
Read Announcement
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:
- December 17, 2025
- Indication:
- first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone.
Announcement
Immuneering Corporation announced that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone.
AI Summary
Immuneering said it is on track to dose the first patient in its global Phase 3 registrational trial, MAPKeeper 301, in mid-2026. The study will test atebimetinib (320 mg once daily) combined with modified gemcitabine and nab-paclitaxel (mGnP) versus standard gemcitabine and nab-paclitaxel (GnP) alone in first-line metastatic pancreatic ductal adenocarcinoma. The trial plans to enroll about 510 patients.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measures. Immuneering expects to report topline results from the Phase 3 study in mid-2028 and plans to provide an overall survival update from its Phase 2a trial in the coming weeks.Read Announcement
- 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.
Read Announcement
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
