On May 23, the U.S. Food and Drug Administration (FDA) 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. NovoTTF-100L is a noninvasive, antimitotic cancer treatment that delivers tumor treating fields to the region of the tumor, a therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.
NovoTTF-100L is the first -treatment for malignant pleural mesothelioma approved by the FDA in more than 15 years. Preclinical data showed that human mesothelioma cells are highly sensitive to tumor treating fields.
The FDA approval is based on the results of the STELLAR trial (ClinicalTrials.gov ID NCT02397928). STELLAR was a prospective, -single-arm trial designed to study the safety and efficacy of NovoTTF-100L plus chemotherapy first-line in patients with unresectable malignant pleural mesothelioma. The trial included 80 patients with unresectable and previously untreated malignant pleural mesothelioma who were candidates for treatment with pemetrexed and cisplatin or carboplatin. The median overall survival was 18.2 months (95% confidence interval = 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 malignant pleural mesothelioma (n = 53) and 12.1 months for patients with nonepithelioid malignant pleural mesothelioma (n = 21). More than half—62%—of patients (n = 80) enrolled in the STELLAR trial who used NovoTTF-100L plus chemotherapy were still alive at 1 year.
NovoTTF-100L for malignant pleural mesothelioma is classified as a Humanitarian Use Device and was approved by the FDA under the Humanitarian Device Exemption. ■
