By Ely Benaim, MD, Chief Medical Officer, Novocure
In April, I had the honor of joining Novocure as the new Chief Medical Officer. It was a good fit, because I wanted to join an organization where I felt I was making a difference in the lives of patients, and I felt that there was no better place to do that than Novocure.
This is because for more than 18 years, Novocure has been a pioneer in cancer research, and has driven forward a revolutionary approach to fight cancer. The company specializes in a treatment called Tumor Treating Fields (TTFields), which uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing affected cancer cells to die. Our research is focused on some of the most hard-to-treat, aggressive cancers, and one cancer in particular is glioblastoma.
Glioblastoma, or GBM, can stop you in your tracks as it is one of the most devastating primary brain cancers there is.1 Yet, this path is changing. That is why I’m here to answer key GBM questions, with the hope of increasing understanding and showcasing some of the important advances.
What is GBM?
GBM is a rare and aggressive form of cancer, and is the most common and deadliest type of malignant primary brain cancer. Annually in the U.S., more than 13,000 people are diagnosed with the tumor.1 You may have heard about it recently because it claimed the lives of notable politicians, John McCain, Ted Kennedy, and Beau Biden. Most patients survive for less than two years.
Why is GBM so hard to treat?
There are many factors that come into play. First, this type of tumor is not always contained in a defined mass with clear borders. Instead, it has thread-like tentacles traveling into nearby areas of the brain, making it incredibly tricky to surgically remove everything.2
Beyond this, surgery is difficult because there needs to be a careful balance made between tumor removal and risks to cognitive function. Unfortunately, following surgery there is difficulty tackling the cancer cells that are left behind, which continue to replicate and multiply.2
Most chemotherapies have limited or no effectiveness for GBM because they cannot cross the blood-brain barrier. Finally, the genetic makeup of the cells within the GBM and amongst patients differs, so there is a need for multiple and/or combination therapies.3
What treatments are available for GBM patients?
Unfortunately, the fact of the matter is that there are limited FDA-approved therapeutic options for GBM, compounding the poor patient prognosis. Treatment for newly diagnosed GBM involves surgical removal of the tumor bulk, followed by radiation and chemotherapy with a drug called temozolomide (which is able to cross the blood-brain barrier).4
Looking at this disease in a different way is key to advancing treatment, and Novocure did just that. As I mentioned before, Novocure delivers an innovative cancer therapy through a technology called Tumor Treating Fields (TTFields). The first commercially available therapy using this technology was Optune®, which was FDA approved in 2011 under the Premarket Authorization (PMA) pathway initially in the recurrent setting for GBM, and then ultimately for patients with newly diagnosed GBM in 2015. The approval in newly diagnosed patients was based on a large clinical study that showed unprecedented survival rates. Patients using Optune with temozolomide had a greater opportunity to live longer than those who used temozolomide alone (13% vs 5% at five years, respectively).5 To learn more, visit our site.
What else is Novocure doing in the cancer space?
First and foremost, patients remain at the heart of the work we do every day. They are what matters most to us, guiding us forward in our mission to deliver a completely different cancer therapy that could lengthen patients’ lives while maintaining their quality of life.
The science of TTFields has already extended beyond GBM with the potential to impact patients’ with other tumor solid tumor types. We recently received approval for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) with standard chemotherapy under the Humanitarian Device Exemption (HDE) pathway. Additionally, there are Phase 3 trials currently open and enrolling in four other types of cancer. To learn more, please visit www.novocure.com.
Indications For Use
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 debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
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.
The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
Important Safety Information
Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. Do not use the NovoTTF-100L System in patients with MPM with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc.
Use of Optune for GBM or the NovoTTF-100L System for MPM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use Optune for GBM or the NovoTTF-100L System for MPM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune and the NovoTTF-100L System may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions
Optune and the NovoTTF-100L System can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure®.
The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.
The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.
The most common (≥10%) adverse events involving the NovoTTF-100L System in combination with chemotherapy in patients with MPM were anemia, constipation, nausea, asthenia, chest pain, fatigue, device skin reaction, pruritus, and cough.
Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical site reaction and skin breakdown/skin ulcer.
If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment and the NovoTTF-100L System.
Do not prescribe Optune or the NovoTTF-100L System for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of the NovoTTF-100L System and Optune in these populations have not been established.
Caution: Federal law restricts the NovoTTF-100L System to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.
1Ostrom QT, Glittleman H, Truitt G, Boscia A, Kruchko C, Bamholtz-Sloan JS. CBTRUS Statistical report: Primary brain and other central nervous system tumors diagnosed in the United States in 2011-2015. Neuro Oncol. 2018;20(suppl 4):iv1-iv8.6.
2Lara-Velazquez M, Al-Kharboosh R, Jeanneret S, et al. Advances in Brain Tumor Surgery for Glioblastoma in Adults. Brain Sci. 2017;7(12):166. doi:10.3390/brainsci7120166.
3Harder BG, Blomquist MR, Wang J, et al. Developments in Blood-Brain Barrier Penetrance and Drug Repurposing for Improved Treatment of Glioblastoma. Front Oncol. 2018;8:462. doi: 10.3389/fonc.2018.00462.
4Patel M, McCully C, Godwin K, Balis FM. Plasma and cerebrospinal fluid pharmacokinetics of intravenous temozolomide in non-human primates. J Neurooncol. 2003;61(3):203-207.
5Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316.
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