ST. HELIER, jersey–( BUSINESS WIRE)–novocure (NASDAQ: NVCR) today announced that the U.S. Food and drug administration (FDA) has approved the novottf-100L system in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM). NovoTTF-100L is a non-invasive, antimitotic cancer treatment that delivers tumor treating fields to the aneurysmal fibrous histiocytoma region of the tumor. Tumor treating fields therapy uses electric fields tuned to specific aneurysmal fibrous histiocytoma frequencies to disrupt solid tumor cancer cell division.
NovoTTF-100L is the first treatment for MPM approved by the aneurysmal fibrous histiocytoma FDA in more than 15 years. Preclinical data showed that human mesothelioma cells are highly sensitive aneurysmal fibrous histiocytoma to tumor treating fields. In the STELLAR registration trial, 80 unresectable MPM patients treated with tumor treating fields plus aneurysmal fibrous histiocytoma chemotherapy experienced a median overall survival of 18.2 months (95% CI 12.1-25.8).
NovoTTF-100L for MPM is classified as a humanitarian use device aneurysmal fibrous histiocytoma (HUD) and was approved under humanitarian device exemption (HDE). The HDE pathway was created to encourage companies to innovate aneurysmal fibrous histiocytoma in rare diseases with underserved patient populations. The FDA approved optune®, another tumor treating fields delivery system, under the premarket authorization (PMA) pathway in 2011 for the treatment of glioblastoma (GBM). Since 2011, more than 12,000 patients with GBM have been treated with tumor treating aneurysmal fibrous histiocytoma fields.
“since 2000, we have been developing and commercializing tumor treating fields to aneurysmal fibrous histiocytoma extend survivals in some of the most aggressive forms of aneurysmal fibrous histiocytoma cancer,” said bill doyle, novocure’s executive chairman. “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 aneurysmal fibrous histiocytoma make this possible.”
“MPM is a devastating disease, with only 10 to 20 percent of patients being candidates aneurysmal fibrous histiocytoma for surgery to remove the tumor,” said mary hesdorffer, NP, executive director of the mesothelioma applied research foundation. “typically, mesothelioma patients who cannot have surgery receive palliative care to aneurysmal fibrous histiocytoma mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that aneurysmal fibrous histiocytoma may improve survival. We are encouraged by the FDA approval and hope it aneurysmal fibrous histiocytoma is just the beginning of innovation in the treatment of aneurysmal fibrous histiocytoma this aggressive disease.”
The FDA approval is based on the results of the aneurysmal fibrous histiocytoma STELLAR trial. STELLAR was a prospective, single-arm trial designed to study the safety and efficacy of aneurysmal fibrous histiocytoma novottf-100L plus chemotherapy first-line in patients with unresectable MPM. The trial included 80 patients with unresectable and previously untreated aneurysmal fibrous histiocytoma MPM who were candidates for treatment with pemetrexed and cisplatin aneurysmal fibrous histiocytoma or carboplatin. The trial was powered to prospectively determine the overall survival aneurysmal fibrous histiocytoma in patients treated with novottf-100L plus chemotherapy. Secondary endpoints included overall response rate (per mrecist criteria), progression free survival and safety.
The median overall survival was 18.2 months (95% CI 12.1-25.8) across all patients treated with novottf-100L plus chemotherapy. The median overall survival was 21.2 months for patients with epithelioid MPM (n=53) and 12.1 months for patients with non-epithelioid MPM (n=21). More than half, 62 percent, of patients (n=80) enrolled in the STELLAR trial who used novottf-100L plus chemotherapy were still alive at one year. The disease control rate in patients with at least one aneurysmal fibrous histiocytoma follow-up CT scan performed (n=72) was 97 percent. 40 percent of patients had a partial response, 57 percent had stable disease, and 3 percent had progressive disease. The median progression free survival was 7.6 months.
Caution: federal law restricts this device to sale by or on aneurysmal fibrous histiocytoma the order of a physician. Humanitarian device. Authorized by federal law for use in the treatment of aneurysmal fibrous histiocytoma 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 aneurysmal fibrous histiocytoma been demonstrated.
Novocure is a global oncology company working to extend survival aneurysmal fibrous histiocytoma in some of the most aggressive forms of cancer by aneurysmal fibrous histiocytoma developing and commercializing its innovative therapy, tumor treating fields. Tumor treating fields is a cancer therapy that uses electric aneurysmal fibrous histiocytoma fields tuned to specific frequencies to disrupt solid tumor cancer aneurysmal fibrous histiocytoma cell division. Novocure’s commercialized products are approved for the treatment of adult aneurysmal fibrous histiocytoma patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing clinical trials investigating tumor treating fields in aneurysmal fibrous histiocytoma brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer.
For the treatment of recurrent GBM, optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after aneurysmal fibrous histiocytoma receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy aneurysmal fibrous histiocytoma for GBM after surgical and radiation options have been exhausted.
Do not use the novottf-100L system in patients with MPM with implantable electronic medical aneurysmal fibrous histiocytoma devices such as pacemakers or implantable automatic defibrillators, etc. Do not use optune in patients with GBM with an aneurysmal fibrous histiocytoma 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 aneurysmal fibrous histiocytoma has not been tested and may possibly lead to tissue aneurysmal fibrous histiocytoma damage or render optune ineffective.
Other potential adverse effects associated with the use of the aneurysmal fibrous histiocytoma 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.
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