Some patients with rare asbestos-related cancer now have a new treatment option. The Food and Drug Administration (FDA) announced that it has approved the first mesothelioma treatment in 15 years – a tumor treating fields (TTF) device designed to be used in combination with pemetrexed plus platinum-based chemotherapy. It is designed as a first-line treatment for unresectable, locally advanced or metastatic, malignant pleural mesothelioma.

The device, made by Novocure, is called the NovoTTF-100L System. The device uses electric fields to disrupt solid tumor cancer cell division. A similar device, also made by Novocure, is currently used to treat gioblastoma, a type of brain cancer.

Previously, the chemotherapy pemetrexed plus the platinum-based chemotherapy cisplatin was the only FDA-approved therapy for unresectable malignant pleural mesothelioma.

Mesothelioma is a rare but deadly form of cancer caused by asbestos exposure. It develops in the lining of internal organs. Pleural mesothelioma affects the lining of the lungs. The disease can take up to 50 years from initial asbestos exposure to develop. Once diagnosed, it can prove deadly within one to two years.

The NovoTTF-100L System was approved under the FDA’s Humanitarian Device Exemption, a clearance process designed to encourage innovation in rare diseases. It allows medical devices to be marketed without evidence of effectiveness.

The approval of NovoTTF-100L was based on a single-arm trial using the device plus chemotherapy as a first line treatment for patients with unresectable malignant pleural mesothelioma. Of the 80 patients with unresectable malignant pleural mesothelioma enrolled in the study, the median overall survival was 18.2 months. Median progression-free survival was 7.6 months.

Novocure acknowledged in a statement that, “the effectiveness of this device for this use has not been demonstrated.”

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