The Food and Drug Administration (FDA) has approved the NovoTTF-100L System (Novocure) in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM).
The NovoTTF-100L System is a non-invasive, antimitotic cancer therapy that utilizes electric fields (Tumor Treating Fields) tuned to specific frequencies to disrupt solid tumor cancer cell division. The approval was based on data from the STELLAR trial which evaluated the safety and efficacy of NovoTTF-100L plus chemotherapy in patients with unresectable MPM (N=80).
Results showed that patients treated with NovoTTF-100L plus chemotherapy had a median overall survival of 18.2 months (95% CI 12.1-25.8), while median progression free survival (secondary endpoint) was 7.6 months. The study also showed that combining NovoTTF-100L with chemotherapy did not result in an increase in serious adverse reactions; mild to moderate skin irritation was the most common device-related adverse effect.
“MPM is a devastating disease, with only 10 to 20% of patients being candidates for surgery to remove the tumor,” said Mary Hesdorffer, NP, Executive Director of the Mesothelioma Applied Research Foundation. “NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival.
Prior to this approval, pemetrexed (Alimta; Lilly), in combination with cisplatin, was the only FDA-approved therapy for the initial treatment of MPM in patients whose disease is unresectable or who are otherwise not candidates for curative surgery.
Before prescribing NovoTTF-100L, healthcare providers must complete the required certification training. The NovoTTF-100L System should not be used in patients with implantable electronic medical devices (ie, pacemakers, implantable automatic defibrillators) or in patients with known sensitivity to conductive hydrogels.
For more information visit novocure.com