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NovoCure's Cancer Treatment Device Option Pax Gets European Approval
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Key Takeaways
NVCR won CE mark approval for Optune Pax to treat locally advanced pancreatic cancer in Europe.
NVCR's Optune Pax launch in Europe begins in the coming weeks, starting with Germany.
NVCR's PANOVA-3 data showed Optune Pax improved survival and significantly delayed pain progression.
NovoCure Limited (NVCR - Free Report) recently announced that its portable medical device, Option Pax, has received the CE (Conformité Européenne) mark for treating adult patients with locally advanced pancreatic cancer of exocrine origin. The non-invasive device is approved in Europe in concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations. The guideline recommendations account for the local differences as use of gemcitabine and nab-paclitaxel may vary by market.
NVCR plans to initiate the launch of Option Pax in Europe in the upcoming weeks, beginning with Germany.
The device-drug combination already received FDA nod earlier this year, becoming the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
The CE-mark and FDA approval for Option Pax concomitant with gem/nab-pac were supported by data from successfully completed phase III PANOVA-3 study. The late-stage study met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS), as well as significantly extended time to pain progression, a key secondary endpoint.
Price Performance
Despite the European approval, shares of NovoCure closed 2.1% down yesterday. The company’s shares have gained 17.2% so far this year compared with the industry’s growth of 6.4%. The S&P 500 Index has increased 8.9% in the same period.
Image Source: Zacks Investment Research
Treatment options for pancreatic cancer remain limited, and survival rates continue to be low because the disease is often diagnosed at an advanced stage, when tumors are more difficult to treat. The promising study data for Option Pax, especially for advanced stage pancreatic cancer patients, may drive strong adoption as a treatment option, boosting sales for the company across the United States and Europe.
More on the News
Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells.
The PANOVA-3 study evaluated Option Pax concomitantly with gem/nab-pac and gem/nab-pac alone. The patients were observed for a minimum of 18 months. In the intent-to-treat (ITT) population, Optune Pax concomitantly with gem/nab-pac achieved a mOS of 16.2 months compared to 14.2 months for gem/nab-pac alone. This shows a statistically significant 2.0-month improvement.
The company also compared the treatment options in the modified ITT population (mITT), defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac or at least one complete cycle of gem/nab-pac. Optune Pax concomitantly with gem/nab-pac achieved a statistically significant 3.2-month improvement compared to gem/nab-pac alone.
The one-year survival rate in the ITT population showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 68.1% compared to those who received gem/nab-pac alone, 60.2%. Optune Pax concomitant with gem/nab-pac also achieved significant 6.1-month extension in time to pain progression.
There was no significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the Optune Pax concomitant with gem/nab-pac and the gem/nab-pac alone arms.
Industry Prospect
Per a Grand View Research report, the global pancreatic cancer market was valued at $2.92 billion in 2024, which is expected to reach $5.84 billion in 20230, at a CAGR of 12.3%.
The solid growth expectation for the pancreatic cancer market looks promising for NVCR’s Option Pax. A rising prevalence of pancreatic cancer should boost demand for this non-invasive treatment option.
Some better-ranked stocks from the broader medical space are BrightSpring Health (BTSG - Free Report) , Globus Medical (GMED - Free Report) andWest Pharmaceutical (WST - Free Report) .
BrightSpring Health, currently sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2026 adjusted earnings per share (EPS) of 39 cents, which beat the Zacks Consensus Estimate by 34.5%. Revenues of $3.61 billion surpassed the Zacks Consensus Estimate by 8.35%. You can see the complete list of today’s Zacks #1 Rank stocks here.
BrightSpring Health has an estimated long-term earnings growth rate of 46.5%. BTSG’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 14.6%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported a first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
GMED has an estimated long-term earnings growth rate of 10.2%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
West Pharmaceutical, carrying a Zacks Rank #2 at present, reported first-quarter 2026 EPS of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
View the Zacks #1 Rank List
Image: Bigstock
NovoCure's Cancer Treatment Device Option Pax Gets European Approval
Key Takeaways
NovoCure Limited (NVCR - Free Report) recently announced that its portable medical device, Option Pax, has received the CE (Conformité Européenne) mark for treating adult patients with locally advanced pancreatic cancer of exocrine origin. The non-invasive device is approved in Europe in concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations. The guideline recommendations account for the local differences as use of gemcitabine and nab-paclitaxel may vary by market.
NVCR plans to initiate the launch of Option Pax in Europe in the upcoming weeks, beginning with Germany.
The device-drug combination already received FDA nod earlier this year, becoming the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
The CE-mark and FDA approval for Option Pax concomitant with gem/nab-pac were supported by data from successfully completed phase III PANOVA-3 study. The late-stage study met its primary endpoint by demonstrating a statistically significant improvement in median overall survival (mOS), as well as significantly extended time to pain progression, a key secondary endpoint.
Price Performance
Despite the European approval, shares of NovoCure closed 2.1% down yesterday. The company’s shares have gained 17.2% so far this year compared with the industry’s growth of 6.4%. The S&P 500 Index has increased 8.9% in the same period.
Image Source: Zacks Investment Research
Treatment options for pancreatic cancer remain limited, and survival rates continue to be low because the disease is often diagnosed at an advanced stage, when tumors are more difficult to treat. The promising study data for Option Pax, especially for advanced stage pancreatic cancer patients, may drive strong adoption as a treatment option, boosting sales for the company across the United States and Europe.
More on the News
Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells.
The PANOVA-3 study evaluated Option Pax concomitantly with gem/nab-pac and gem/nab-pac alone. The patients were observed for a minimum of 18 months. In the intent-to-treat (ITT) population, Optune Pax concomitantly with gem/nab-pac achieved a mOS of 16.2 months compared to 14.2 months for gem/nab-pac alone. This shows a statistically significant 2.0-month improvement.
The company also compared the treatment options in the modified ITT population (mITT), defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac or at least one complete cycle of gem/nab-pac. Optune Pax concomitantly with gem/nab-pac achieved a statistically significant 3.2-month improvement compared to gem/nab-pac alone.
The one-year survival rate in the ITT population showed a significant improvement in the Optune Pax concomitant with gem/nab-pac treated group with 68.1% compared to those who received gem/nab-pac alone, 60.2%. Optune Pax concomitant with gem/nab-pac also achieved significant 6.1-month extension in time to pain progression.
There was no significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the Optune Pax concomitant with gem/nab-pac and the gem/nab-pac alone arms.
Industry Prospect
Per a Grand View Research report, the global pancreatic cancer market was valued at $2.92 billion in 2024, which is expected to reach $5.84 billion in 20230, at a CAGR of 12.3%.
The solid growth expectation for the pancreatic cancer market looks promising for NVCR’s Option Pax. A rising prevalence of pancreatic cancer should boost demand for this non-invasive treatment option.
NovoCure Limited Price
NovoCure Limited price | NovoCure Limited Quote
NVCR’s Zacks Rank & Key Picks
Currently, NovoCure has a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are BrightSpring Health (BTSG - Free Report) , Globus Medical (GMED - Free Report) andWest Pharmaceutical (WST - Free Report) .
BrightSpring Health, currently sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2026 adjusted earnings per share (EPS) of 39 cents, which beat the Zacks Consensus Estimate by 34.5%. Revenues of $3.61 billion surpassed the Zacks Consensus Estimate by 8.35%. You can see the complete list of today’s Zacks #1 Rank stocks here.
BrightSpring Health has an estimated long-term earnings growth rate of 46.5%. BTSG’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 14.6%.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported a first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
GMED has an estimated long-term earnings growth rate of 10.2%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
West Pharmaceutical, carrying a Zacks Rank #2 at present, reported first-quarter 2026 EPS of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.