In May 2019, the U.S. Food and Drug Administration (FDA) approved a new treatment for malignant pleural mesothelioma (MPM). It's the first mesothelioma treatment introduced in 15 years.
Manufactured by Novocure, the NovoTTF-100L is the newest treatment option for MPM since Pemetrexed. Also known as Alimta, Pemetrexed was approved in 2004. The new mesothelioma treatment consists of a tumor treating fields (TTF) device used in combination with Pemetrexed plus platinum-based chemotherapy.
The TTF device uses electric fields to stop cancer cell reproduction in solid tumors. It's intended for MPM patients with unresectable (unable to be surgically removed), locally advanced (occurring outside the lungs) or metastatic cancer (spreading throughout the body).
Prior to the FDA mesothelioma treatment approval, Novocure built a reputation with its product Optune. Optune was approved to treat glioblastoma, a type of brain cancer, in 2011.
NovoTTF-100L was approved under the FDA Humanitarian Device Exemption, which is an expedited regulatory pathway intended to approve treatments for rare diseases. It creates exemptions from certain effectiveness requirements. Though the NovoTTF-100L’s approval is based on the STELLAR trial results, it's a new device and it will require observation going forward.
Many, however, are optimistic. Mary Hesdorffer, nurse practitioner and executive director of the Mesothelioma Applied Research Foundation, voiced her approval of the new product in a press conference. Hesdorffer stated it “provides unresectable MPM patients with a treatment option that may improve survival.”
For many patients struggling with MPM, the approval reminds them that they are not forgotten.