The Food and Drug Administration has approved the 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).
The NovoTTF-100L System uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division, Novocure, makers of NovoTTF-100L, said in a.
FDA approval was based on the single-arm STELLAR registration trial, which included 80 patients with unresectable and previously untreated MPM who were candidates for treatment with pemetrexed and cisplatin or carboplatin.
Median overall survival among all patients treated with NovoTTF-100L plus chemotherapy was 18.2 months (95% confidence interval, 12.1-25.8). The disease control rate in the 72 patients with at least one follow-up CT scan performed was 97%; 40% of patients had a partial response, 57% had stable disease, and 3% had progressive disease. The median progression free survival was 7.6 months.
The most common adverse events observed with the NovoTTF-100L System in combination with chemotherapy in patients with MPM were anemia, constipation, nausea, asthenia, chest pain, fatigue, device skin reaction, pruritus, and cough.
Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical site reaction, and skin breakdown/skin ulcer.
The NovoTTF-100L System can be prescribed only by a health care provider who has completed the required certification training provided by Novocure, the company said in the press release.