Novocure Wins FDA Approval for First Mesothelioma Treatment in 15 Years

FDA Approval

Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.

Novocure, based in the U.K., said the U.S. Food and Drug Administration (FDA) approved NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy as a first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma. This marks the first FDA approval for malignant pleural mesothelioma (MPM) in 15 years, Novocure said in its announcement.

NovoTTF-100L is a non-invasive, antimitotic cancer treatment that delivers Tumor Treating Fields to the region of the tumor, the company said. Tumor Treating Fields therapy uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division, Novocure said in its announcement.

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Bill Doyle, Novocure’s executive chairman of the board, said the approval of NovoTTF-100L is a major milestone for the company as it marks its first FDA-approved torso cancer indication.

The FDA approval was based on results from the Phase III STELLAR Trial that demonstrated the efficacy of the NovoTTF-100L System. In that trial, 80 unresectable MPM patients treated with Tumor Treating Fields plus chemotherapy experienced a median overall survival of 18.2 months. MPM is a rare cancer that has been strongly linked to asbestos exposure. Approximately 3,000 people are diagnosed with MPM in the United States annually. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM.

The median overall survival was 21.2 months for patients with epithelioid MPM and 12.1 months for patients with non-epithelioid MPM. 62% of patients enrolled in the STELLAR trial who used NovoTTF-100L plus chemotherapy were still alive at one year.

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

NovoTTF-100L for MPM is classified as a Humanitarian Use Device (HUD) and was approved under Humanitarian Device Exemption (HDE). The pathway was created to encourage companies to innovate in rare diseases with underserved patient populations. The pathway does have a limitation on how many devices can be sold for profit, according to the FDA website.

The HDE pathway is not the only unique FDA authorization Novocure has benefitted from. In 2011, it received approval for Optune, another Tumor Treating Fields delivery system, under the Premarket Authorization (PMA) pathway for the treatment of glioblastoma. Since that approval, more than 12,000 glioblastoma patients have been treated with the company’s Tumor Treating Fields, Novocure said.

In March, Novocure launched a Phase III trial testing the efficacy of Tumor Treating Fields combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer.

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