News about approvals or insinuations about almost guaranteed future approvals of products that promise improving the management of chronic and life-threatening diseases are always welcomed with enthusiasm. Of course some approvals are more rewarding than others, which has to be assessed by investors. For the patients, however, any improvement, small or phenomenal is always considered good news.
Let’s have a look at one of the most recent approvals we learned about and that we believe is making a difference in treating difficult-to-treat conditions.
Recent FDA Approvals
In The NEWS
NOVOCURE
The Food and Drug Administration (FDA) Pre-Market Approval (PMA) supplement application for the firm Novocure’s second generation Optune system.
NovoCure (NVCR)
Headquartered in Jersey Isle, Novocure’s US operations are based in Portsmouth, NH and New York, NY. The firm has offices in Switzerland, Germany and Japan and a research center in Haifa, Israel.
Novocure is cancer specialized company having an approved and marketed treatment for solid tumors called Tumor Treating Fields, or TTFields with a delivery system known as Optune System. The TTFields are low intensity, alternating electric fields proven to disrupt cell division through physical interactions with key molecules during mitosis.TTFields became a non-invasive treatment for solid tumors. As a matter of fact, they have been approved for the treatment of the he brain cancer glioblastoma multiforme (GBM).
The TTFields Therapy
The TTFields were discovered by Yoram Palti, MD, PhD, the founder of Novocure who is a specialist in electrophysiology and biophysics. Dr. Palti began to explore the potential of electrical fields as a cancer treatment in the late 1990s. He set up a laboratory in the basement of his home in 2000 where Novocure was born.
The TTFields therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region surrounding the tumor.
TTFields therapy does not deliver electric current to the tissue. The therapy does not stimulate nerves or muscles and does not heat tissue. TTFields therapy creates an alternating electric field within the tumor that attracts and repels the charged components of the cells during mitosis.
TTFields therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region surrounding the tumor. The complete delivery system, the Optune System includes a portable electric field generator, transducer arrays, rechargeable batteries and more. The therapy is designed to be worn continuously throughout the day and night. The delivery system is portable and is designed to allow patients to go about their daily activities while receiving treatment. All the patients has to learn is how to change and recharge depleted device batteries and
to connect to an external power supply overnight. Also, the transducer arrays need to be replaced once to twice a week and the scalp re-shaved in order to maintain optimal contact. Patients carry the device in an over-the-shoulder bag or backpack and receive continuous treatment without changing their daily routine.
Optune is intended for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal de-bulking surgery and completion of radiation therapy together with standard of care chemotherapy
In the United States, Optune with temozolomide is indicated for the treatment ofrecurrent GBM.
Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
THE FDA APPROVAL
Of Second-Generation TTFields Delivery System Optune
The newly FDA approved second-generation version of the Tumor Treating Fields (TTFields) delivery system is designed to make treatment with the TTFields more convenient and manageable for GBM patients.
The new TTFields generator is less than half the size of the the first-generation Optune system and weighs 2.7 pounds only, i.e., less than have the old system’s weight.
This new system has now become available in the U.S. for glioblastoma (GBM) patients.
Additional improvements include: Easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.
Novocure offered the second generation Optune system to patients in Germany in October 2015 and has since made it available to all new patients in Europe and now, the U.S. patients are getting it.
Mike Ambrogi, Novocure’s Chief Operating Officer said that the firm has received positive feedback from the second generation Optune patients in Europe, and that the firm is excited to roll out our new device to patients in the United States.
Novocure will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.
Optune Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal de-bulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy in the United States, for the treatment of recurrent GBM,
Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Prohost Observations
NovoTTF Therapy is a novel treatment that the FDA approved as an antimitotic treatment for recurrent GBM, as it demonstrated potential benefits compared with other options.
A study by Josef Vymazal and Eric T. Wong published in Seminars in Oncology states that Recurrent GBM patients from two prior trials with demonstrated radiologic tumor response to single-agent NovoTTF Therapy were analyzed to better characterize tumor response patterns and evaluate the associations between response, compliance, and OS. In addition, a compartmental tumor growth model was developed and evaluated for its ability to predict GBM response to tumor-treating fields (TTFields).
The overall response rate across both trials was 15%
(4% complete responses): 14% in the phase 3 trial (14/120) and 20% (2/10) in a pilot study.)
Tumor responses to NovoTTF Therapy developed slowly (median time to response, 5.2 months) but were durable (median duration, 12.9 months).
Response duration was highly correlated with overall survival and OS
Median OS for responders was 24.8 months. Seven of 16 responders exhibited initial tumor growth on magnetic resonance imaging.
Compliance appeared to be linked with both improved response and survival.
The tumor growth model predicted tumor arrest and shrinkage only after several weeks of continuous NovoTTF Therapy, consistent with the observed clinical findings of initial transient tumor growth in some patients.
In conclusion, the NovoTTF Therapy antimitotic treatment for recurrent GBM is associated with slowly developing but durable tumor responses in approximately 15% of patients. Some responders exhibit initial tumor growth before shrinkage, indicating treatment should not be terminated prior to allowing for the full effect of NovoTTF Therapy to be realized. OS is longer in responders than in non-responders. High daily compliance rates may be associated with increased likelihood of an objective response and are predictive of improved survival.
The FDA approval of the second-generation Optune, we believe, will further increase compliance. Prohost believes tat this is good news for glioblastoma patients and further studies and possibly new combination treatments, we believe, might improve the results.
Stock Symbol: NVCR
Stock Price: $11.60
Market Cap: $981.88 M
We will follow up on this innovative firm. An Important Approval Will Be Posted Under Today’s Highlights
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
NOVOCURE: The FDA Approves the Firm’s Second Generation Non-Invasive Treatment for Glioblastoma
News about approvals or insinuations about almost guaranteed future approvals of products that promise improving the management of chronic and life-threatening diseases are always welcomed with enthusiasm. Of course some approvals are more rewarding than others, which has to be assessed by investors. For the patients, however, any improvement, small or phenomenal is always considered good news.
Let’s have a look at one of the most recent approvals we learned about and that we believe is making a difference in treating difficult-to-treat conditions.
Recent FDA Approvals
In The NEWS
NOVOCURE
The Food and Drug Administration (FDA) Pre-Market Approval (PMA) supplement application for the firm Novocure’s second generation Optune system.
NovoCure (NVCR)
Headquartered in Jersey Isle, Novocure’s US operations are based in Portsmouth, NH and New York, NY. The firm has offices in Switzerland, Germany and Japan and a research center in Haifa, Israel.
Novocure is cancer specialized company having an approved and marketed treatment for solid tumors called Tumor Treating Fields, or TTFields with a delivery system known as Optune System. The TTFields are low intensity, alternating electric fields proven to disrupt cell division through physical interactions with key molecules during mitosis.TTFields became a non-invasive treatment for solid tumors. As a matter of fact, they have been approved for the treatment of the he brain cancer glioblastoma multiforme (GBM).
The TTFields Therapy
The TTFields were discovered by Yoram Palti, MD, PhD, the founder of Novocure who is a specialist in electrophysiology and biophysics. Dr. Palti began to explore the potential of electrical fields as a cancer treatment in the late 1990s. He set up a laboratory in the basement of his home in 2000 where Novocure was born.
The TTFields therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region surrounding the tumor.
TTFields therapy does not deliver electric current to the tissue. The therapy does not stimulate nerves or muscles and does not heat tissue. TTFields therapy creates an alternating electric field within the tumor that attracts and repels the charged components of the cells during mitosis.
TTFields therapy is delivered using non-invasive, insulated transducer arrays that are placed directly on the skin in the region surrounding the tumor. The complete delivery system, the Optune System includes a portable electric field generator, transducer arrays, rechargeable batteries and more. The therapy is designed to be worn continuously throughout the day and night. The delivery system is portable and is designed to allow patients to go about their daily activities while receiving treatment. All the patients has to learn is how to change and recharge depleted device batteries and
to connect to an external power supply overnight. Also, the transducer arrays need to be replaced once to twice a week and the scalp re-shaved in order to maintain optimal contact. Patients carry the device in an over-the-shoulder bag or backpack and receive continuous treatment without changing their daily routine.
Optune is intended for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal de-bulking surgery and completion of radiation therapy together with standard of care chemotherapy
In the United States, Optune with temozolomide is indicated for the treatment ofrecurrent GBM.
Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
THE FDA APPROVAL
Of Second-Generation TTFields Delivery System Optune
The newly FDA approved second-generation version of the Tumor Treating Fields (TTFields) delivery system is designed to make treatment with the TTFields more convenient and manageable for GBM patients.
The new TTFields generator is less than half the size of the the first-generation Optune system and weighs 2.7 pounds only, i.e., less than have the old system’s weight.
This new system has now become available in the U.S. for glioblastoma (GBM) patients.
Additional improvements include: Easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.
Novocure offered the second generation Optune system to patients in Germany in October 2015 and has since made it available to all new patients in Europe and now, the U.S. patients are getting it.
Mike Ambrogi, Novocure’s Chief Operating Officer said that the firm has received positive feedback from the second generation Optune patients in Europe, and that the firm is excited to roll out our new device to patients in the United States.
Novocure will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.
Optune Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal de-bulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy in the United States, for the treatment of recurrent GBM,
Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Prohost Observations
NovoTTF Therapy is a novel treatment that the FDA approved as an antimitotic treatment for recurrent GBM, as it demonstrated potential benefits compared with other options.
A study by Josef Vymazal and Eric T. Wong published in Seminars in Oncology states that Recurrent GBM patients from two prior trials with demonstrated radiologic tumor response to single-agent NovoTTF Therapy were analyzed to better characterize tumor response patterns and evaluate the associations between response, compliance, and OS. In addition, a compartmental tumor growth model was developed and evaluated for its ability to predict GBM response to tumor-treating fields (TTFields).
The overall response rate across both trials was 15%
(4% complete responses): 14% in the phase 3 trial (14/120) and 20% (2/10) in a pilot study.)
Tumor responses to NovoTTF Therapy developed slowly (median time to response, 5.2 months) but were durable (median duration, 12.9 months).
Response duration was highly correlated with overall survival and OS
Median OS for responders was 24.8 months. Seven of 16 responders exhibited initial tumor growth on magnetic resonance imaging.
Compliance appeared to be linked with both improved response and survival.
The tumor growth model predicted tumor arrest and shrinkage only after several weeks of continuous NovoTTF Therapy, consistent with the observed clinical findings of initial transient tumor growth in some patients.
In conclusion, the NovoTTF Therapy antimitotic treatment for recurrent GBM is associated with slowly developing but durable tumor responses in approximately 15% of patients. Some responders exhibit initial tumor growth before shrinkage, indicating treatment should not be terminated prior to allowing for the full effect of NovoTTF Therapy to be realized. OS is longer in responders than in non-responders. High daily compliance rates may be associated with increased likelihood of an objective response and are predictive of improved survival.
The FDA approval of the second-generation Optune, we believe, will further increase compliance. Prohost believes tat this is good news for glioblastoma patients and further studies and possibly new combination treatments, we believe, might improve the results.
Stock Symbol: NVCR
Stock Price: $11.60
Market Cap: $981.88 M
We will follow up on this innovative firm. An Important Approval Will Be Posted Under Today’s Highlights
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
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