For the First Time in 15 Years, FDA Approves Mesothelioma Treatment

The Food and Drug Administration (FDA) has approved NovoTTF-100L System from manufacturer Novocure in conjunction with pemetrexed plus platinum-based chemotherapy to treat unresectable malignant pleural mesothelioma (MPM). It is the first MPM treatment in 15 years to receive the FDA’s approval—the last approved treatment was pemetrexed.

The NovoTTF-100L System is a tumor treating fields (TTF) device indicated for treating tumors that cannot be removed by surgery. According to Novocure’s website, in TTF therapy, low intensity electric fields are used to disrupt cell division in cancerous tumors. It is a non-invasive treatment. The portable NovoTTF-100L System is used in the patient’s home by a licensed physician who may train the patient’s caregivers. Patients receive the electric fields through transducer arrays connected to the device and the patient’s chest. It is indicated for use at least 18 hours a day with small breaks and can be plugged into a power supply or operate with a rechargeable battery to allow the patient movement.

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

“MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor,” added Mary Hesdorffer, NP, executive director of the Mesothelioma Applied Research Foundation. “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.”

STELLAR Trial Measures NovoTTF-100L System Efficacy

TTF therapy was tested in the phase 2 STELLAR trial, which included 80 patients with unresectable, untreated mesothelioma who received continuous 150 kHz TTF in combination with pemetrexed and platinum. Patients were followed for at least one year. The study’s primary endpoint was overall survival. Outcomes were compared to those of historical controls.

Median age among the total cohort was 67 years (range 27-78 years). Most patients (84%) were male, 66% had epithelioid histology, more than half (56%) were smokers, 44% had an ECOG Performance Status of 1, and 16% had metastatic disease.

For the first three months, 68% of patients complied with treatment (16.3 hours/day). Median overall survival was 18.2 months, about six months more than that of historical controls, and median progression-free survival was 7.6 months in the TTF group versus 5.7 months in the historical control group. No serious adverse events were observed, and the most common side effect was skin rash or irritation, which went away after stopping treatment.

Sources: FDA, Medscape, Novocure