Novocure’s tumor-treating electric field system scored a first-line FDA approval in mesothelioma, making it the first new treatment option in the indication in more than 15 years.
Given as an add-on to the previously approved combination of Eli Lilly’s lung cancer drug Alimta and cisplatin chemotherapy, Novocure’s device uses electromagnetic energy to disrupt the processes of cell division within malignant pleural mesothelioma tumors that cannot be removed through surgery.
The NovoTTF-100L system was classified by the FDA as a humanitarian use device and was approved under a limited-use humanitarian device exemption, which does not require effectiveness to be proven. A single-arm clinical trial of 80 treated patients had demonstrated a median overall survival of 18.2 months and a progression-free survival rate of 7.6 months.
Previously, the combination of Alimta (pemetrexed) and cisplatin chemotherapy, approved by the FDA in 2004, reached median survival rates of about one year in a separate study at the time.
Meanwhile, patients with epithelioid disease fared better under Novocure’s treatment—with a median survival of 21.2 months, compared to the 12.1 months seen in non-epithelioid mesothelioma patients—and there were no increases in serious systemic adverse events, the company said.