The FDA has approved the NovoTTF-100L system combined with chemotherapy for the treatment of malignant pleural mesothelioma. The combination is the first treatment approved by the FDA for malignant pleural mesothelioma in 15 years. Non-invasive NovoTTF-100L is an electrical device that can disrupt locally advanced or metastatic, unresectable MPM cancer cells.
The US Food and Drug Administration- FDA has approved the combination of NovoTTF-100L system and platinum-based chemotherapy for the treatment of malignant pleural mesothelioma on May 23, 2019. Clinical trials have shown significant improvement in the survival rate of patients treated with NovoTTF-100L plus chemotherapy.
In 2004, the FDA had approved chemotherapy pemetrexed Alimta drug as the standard treatment for malignant pleural mesothelioma.
The NovoTTF-100L system is an automatic and non-invasive cancer therapeutic device that utilizes Tumor Treating Fields- TTF (electric fields)set at specific frequencies to damage metastasized or locally advanced mesothelioma tumor cells. The FDA approves this treatment after eight months of the publication of the STELLAR clinical trial results by the manufacturers of this system, Novocure. Novocure’s Executive Chairman, Bill Doyle said,
Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer, FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible.
Shares of Novocure have boosted over 6% in the trading premarket after the announcement of this treatment's approval by the FDA.
What is NovoTTF-100L System?
The NovoTTF-100L system is the first device to be used in combination with two-drug chemotherapy for the treatment of malignant pleural mesothelioma (MPM). To be very precise, this duo of therapy as the first-line treatment for unresectable (unable to remove with the surgery), metastatic or locally advanced MPM.
The NovoTTF-100L system is a HUD- Humanitarian Use Device approved under the HDE- Humanitarian Device Exemption. This portable device uses a comparatively new technology for the treatment of some aggressive cancers.
This device includes a generator, connection cables, transducer arrays, battery, battery charger, power supply, and a bag carrying all this stuff. The patients prescribed with this treatment for home use from a trained, licensed physician. Patients can quickly learn how to use this device with proper care, plus caregivers must also be advised to monitor the device's correct use. This home treatment certainly is a useful protocol for the treatment of malignant pleural mesothelioma.
Executive Director of the Mesothelioma Applied Research Foundation, Mary Hesdorffer, NP said,
MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor, Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease.
How this New Technology Works?
The NovoTTF-100L system generates TTF- tumor treatment fields, which are alternating electric fields. These Tumor Treatment Fields are provided to the patients using adhesive bandages that stick transducer arrays. These arrays are the main task force for the disruption of metastasized tumor cells, inhibition of tumor growth, and increase the chances for the death of cancer cells. The device is used plugged in, or if the patient wants to move around, then the batter can be charged with the charger.
This NovoTTF-100L system must be used for at least 18 hours daily with short breaks to a significant decrease in the disease progression is observed. There is no need to change the device's settings by the patient.
Similar to the recently approved technological device for the treatment of MPM, In 2011 the FDA had approved a TTF- Tumor Treating Fields delivery system under the Premarket Authorization (PMA) pathway, used for the treatment of the most aggressive type of brain cancer, Glioblastoma- GBM. And since 2011, with the help of this TTF system, over 12,000 patients suffering from glioblastoma have been treated.
Who Can Receive this Treatment?
Doctors use the NovoTTF-100L system for the treatment of malignant pleural mesothelioma patients with an unresectable, metastatic, or locally advanced tumor. Doctors implement this system concurrently with platinum-based chemotherapy. Doctors must only order This combination of chemotherapy and NovoTTF-100L for adult patients, those who are 22 years of age or older.
What Can Patients Expect with This Treatment?
In clinical trials, doctors used an experiment called a STELLAR test, here the doctors used the NovoTTF-100L system along with standard 2-drug chemotherapy on 80 patients suffering from unresectable malignant pleural mesothelioma. These patients from previously untreatable MPM and were prescribed to get treated with carboplatin or cisplatin.
The overall survival median of these patients treated with the combination of NovoTTF-100L and chemotherapy was 18 months.
- The overall survival median for patients suffering from epithelioid MPM (53 patients) among these was >21 months.
- And the overall median survival for non-epithelioid MPM patients (21 patients) was >12 months.
- The rate of tumor control was 97%, as checked after at least one follow up CT scan of 72 patients.
- The most common complication associated with this treatment is the development of skin irritation, redness, soreness, and blisters on the patient's skin. Doctors observed These signs in 57 of 80 patients trialed.
Overall, NovoTTF-100L plus chemotherapy promises a high potential to increase life expectancy for MPM patients with the side effects of some skin conditions.
What Are the Precautions for this Technology?
- Both the physicians and the mesothelioma patients must be aware of the side effects of the NovoTTF-100L system, thus to take precautionary measures beforehand.
- About the adverse effects of this approved treatment, among the malignant pleural mesothelioma patients tested for the combination of NovoTTF-100L and chemotherapy, less than 10% complained about constipation, anemia, fatigue, nausea, chest pain, asthenia, cough, pruritus, and skin reactions.
- Other than that, skin toxicity, gel related allergic reactions, skin burns due to the overheated electrode, skin infections at the skin area of electrode contact, muscle twitching, skin ulcer, and tingling sensation at the treated site are some other side effects of this treatment.
- While using NovoTTF-100L system on patients having severed skin condition right at the treated area, the health physician must evaluate whether this treatment be feasible for the patient or not because skin condition may wholly or temporarily interfere with this technological system.
- Lastly, and most importantly, this new mesothelioma treatment tool can be prescribed only by a certified health care provider from Novocure.
Who Should Not Take this Treatment?
Doctors must only prescribe NovoTTF-100L to those mesothelioma patients who do not fall under any of the following categories:
- Patients who have implanted any electronic medical devices such as implantable automatic defibrillators, pacemakers, etc. Because doctors have done no testing on the co-functioning of such automated tools with NovoTTF-100L, the effects are unknown. And a combination of two electric fields together may cause malfunctioning of the implanted electronic device.
- Patients who are allergic to hydrogels. For example, the gel used in the ECG- electrocardiogram or TENS- Electrical Nerve Simulation Electrodes. The gels used in the NovoTTF-100L system may increase redness and itching when in contact with the skin. Moreover, it may heighten the chances of extreme allergic reactions, such as respiratory failure and shock.
- Patients who are pregnant or want to be pregnant must not be administered this treatment. Doctors have not tested the NovoTTF-100L system on patients seeking pregnancy, so the safety measures and the effectiveness of the treatments are not yet known.