Novocure Announces FDA Approval of NovoTTF-100L System as First New Therapy in 15 Years for First-Line Treatment of Malignant Pleural Mesothelioma

Today, Novocure announced that the U.S. FDA has approved the company’s NovoTTF-100L System for marketing, in combination with pemetrexed and platinum-based chemotherapy, as a first-line treatment for unresectable locally advanced or metastatic malignant pleural mesothelioma (MPM). The NovoTTF-100L is a non-invasive, anti-mitotic cancer therapy that uses Tumor Treating Fields to target tumor regions. Notably, the NovoTTF-100L represents the first new therapy for MPM approved by the FDA in 15 years.

Malignant pleural mesothelioma (MPM) is a rare cancer caused by asbestos exposure. Prior to the FDA approval of NovoTTF-100L, the combination therapy of pemetrexed and cisplatin was the only approved treatment for unresectable MPM.

NovoTTF-100L is a system that delivers Tumor Treating Fields to the tumor site. Tumor Treating Fields are low-intensity, alternating electric fields that can affect the movement of specific cellular components during mitosis, thereby disrupting cell division. Due to the unique shape and characteristics of tumor cells during mitosis, adjusting the alternating frequency of the Tumor Treating Fields allows for targeted disruption of tumor cell division. This system has received FDA approval for the treatment of glioblastoma.

▲ Mechanism of Action of Tumor Treating Fields (Image source: Novocure official website)

The FDA’s approval is based on the performance of NovoTTF-100L in the STELLAR clinical trial. In this single-arm clinical trial, 80 patients with malignant pleural mesothelioma (MPM) received first-line treatment with a combination therapy consisting of NovoTTF-100L and chemotherapy. The trial results showed that the median overall survival for patients receiving the combination therapy was 18.2 months. At one year after initiating the combination therapy, 62% of patients were still alive. Among patients who underwent at least one follow-up CT scan, the disease control rate reached 97%, with a partial response rate of 40%.

“MPM is a devastating disease, and only 10–20% of patients are eligible for surgical tumor resection,” said Mary Hesdorffer, Executive Director of the Mesothelioma Applied Research Foundation. “Typically, mesothelioma patients who are not candidates for surgery can only rely on palliative care to alleviate symptoms. NovoTTF-100L offers them a treatment option that may improve survival.”

References:

[1] FDA Approves the NovoTTF-100LTM System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma. Retrieved May 23, 2019, from https://www.businesswire.com/news/home/20190523005776/en/FDA-Approves-NovoTTF-100LTM-System-Combination-Chemotherapy-Treatment

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