FDA Approves Novocure Device for Mesothelioma

FDA has approved a Novocure humanitarian use device for 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 an antimitotic cancer treatment that delivers “tumor treating fields” to the tumor region, according to the company. “Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division,” it says. NovoTTF-100L is the first treatment for MPM approved by FDA in more than 15 years.

Approval is based on preclinical data that showed that human mesothelioma cells are highly sensitive to tumor treating fields, Novocure says. “In the STELLAR registration trial, 80 unresectable MPM patients treated with Tumor Treating Fields plus chemotherapy experienced a median overall survival of 18.2 months,” it says.