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.
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According to the Mesothelioma Applied Research Foundation, only 10% to 20% of patients are candidates for surgery to remove the tumors from the lining of the lungs, while the majority receive palliative care. The progressive cancer has been linked to asbestos exposure, with about 3,000 people being diagnosed annually.
“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” Novocure’s executive chairman, Bill Doyle, said in a statement. “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.”
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The company’s similar Optune system was greenlighted under the agency’s premarket approval pathway in 2011 for glioblastoma in combinations with temozolomide chemotherapy, surgery and radiation. Since then, more than 12,000 adult glioblastoma patients have undergone its electric field treatment, according to Novocure.
In a note to investors, analysts at JPMorgan said that while the device’s approval was not wholly unsurprising given the clinical data in mesothelioma, it did come earlier than expected.
They predict about $300 million in peak sales, despite humanitarian device limitations, with the second approval for the technology potentially supporting broader adoption and applications in the future. Currently, Novocure is conducting later-phase trials in pancreatic, liver, ovarian and non-small cell lung cancers as well as in brain metastases.