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First Mesothelioma Treatment Approved by FDA in 15 Years

The Food and Drug Administration (FDA) has recently approved the NovoTTF-100L system to be used in combination with pemetrexed (aka Alimta) plus platinum-based chemotherapy (Cisplatin or Carboplatin) as a front-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma. This is the first treatment for mesothelioma approved by the FDA since Alimta was approved in 2004.

The NovoTTF-100L system is a portable, lightweight, battery operated device intended for continuous home use by patients. It is a non-invasive, antimitotic cancer therapy that utilizes low intensity alternating electric fields, Tumor Treating Fields (TTFs), to interfere with the division process of cancer cells. The TTFs are delivered to the cancerous region via transducer arrays.

Tumor Treating Fields was first approved by the FDA in 2011 for use with glioblastoma, a type of brain cancer. Uri Weinberg, Novocure's VP for clinical development, said the company's preclinical studies suggest that mesothelioma cells are unusually susceptible to disruption of DNA spindles during mitosis.

FDA approval was based on data from the STELLAR phase II clinical trial, a single-arm trial of 80 patients who had received no prior treatment and were not surgical candidates. Patients treated with the NovoTTF-100L device in addition to a standard chemotherapy regimen of pemetrexed and cisplatin or carboplatin demonstrated a median overall survival of 18.2 months, a significant improvement over the 12.1 months for those receiving only chemotherapy. Patients with epithelioid disease experienced a median survival of 21.2 months. 97.2 percent of patients experienced clinical benefit, including either a partial response or increased disease stability.

There was no increase in serious systemic adverse events when NovoTTF-100L was added to chemotherapy. Mild to moderate skin irritation was the most common device-related side effect with NovoTTF-100L.

Studies utilizing TTFs are currently being conducted for several cancer types including ovarian, pancreatic, gastric and non-small-cell lung cancer.

The NovoTTF-100L System is anticipated to become available for treatment of mesothelioma patients in late 2019 or early 2020.

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