FDA approves Novocure’s NovoTTF-100LTM plus chemo for mesothelioma

NovoCure (NSDQ:NVCR) announced that it has received FDA approval for its NovoTTF-100L system with chemotherapy for treating a type of mesothelioma.

NovoTTF-100L is a non-invasive, antimitotic cancer treatment designed to deliver electric fields at special frequencies to disrupt solid tumor cancer cell division.

Approved under a humanitarian device exemption, NovoTTF-100L and pemetrexed plus platinum-based chemotherapyis indicated for the treatment unresectable, locally advanced or metastatic, malignant pleural mesothelioma, the company said.

“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” chairman Bill Doyle said in a press release. “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 healthcare providers who partnered with us to make this possible.”

Novocure said that preclinical data showed that mesothelioma cells were “highly sensitive” to the system’s tumor treating field. In its Stellar registration trial, 80 unresectable malignant pleural mesothelioma patients were treated with the tumor treating fields from the system and chemotherapy. There was a median overall survival of 18.2 months following treatment.

“MPM is a devastating disease, with only 10% to 20% of patients being candidates for surgery to remove the tumor,” Mary Hesdorffer, executive director of the Mesothelioma Applied Research Foundation, said. “Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease.”