From fall of 2018 through spring of 2019, Novocure embraced a fast-paced dialogue with the U.S. FDA after submitting an application for approval of Optune Lua™, originally known as the NovoTTF-100L System, in combination with chemotherapy for the treatment of malignant pleural mesothelioma (MPM). Optune Lua was submitted for approval under the Humanitarian Device Exemption (HDE) pathway, which was created by the FDA to encourage companies to innovate in rare and underserved diseases.
Maty Ayal Hershkovitz, Vice President of Global Regulatory Affairs, lives and works in Israel, and managed a challenging time difference when questions from the FDA would come in with a tight timeline for response.
“I couldn't believe it myself, but I was writing emails from the supermarket to the FDA,” she said.
As Vice President of Global Regulatory Affairs, Maty oversaw the submission of Optune Lua as a treatment for MPM to the FDA. The role of regulatory affairs, Maty said, is to tell regulatory authorities Novocure’s story per specific device and cancer indication.
“A good story would be something that reflects the fact that we did quality work, that we have a quality device, that the data are solid, and that what we are offering patients is going to be safe and effective,” she said.
Throughout the approval process, the FDA would ask for additional information from Novocure regarding its data in MPM and about the device.
“Whenever FDA had a question, we had the resources, we had the data, we had the science to go back and provide an answer,” Maty said. “That was incredible because those back-and-forth exchanges happened many, many times.”
In May 2019, the FDA approved Optune Lua in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic MPM. Optune Lua is the first new treatment for MPM in more than 15 years.
Maty acknowledged the high level of cooperation she received from colleagues across functions during the approval process.
“I don't take it for granted that you get that kind of cooperation at Novocure,” Maty said. “People understood that if FDA had a question, the response had to be provided quickly.”
Throughout her career, Maty has seen many companies strive to create a pipeline but their innovations may have only been specific to one disease. For Novocure, the FDA approval in MPM broadened the potential use of its therapy.
“This was a breakthrough,” Maty said. “The FDA approval in MPM made Tumor Treating Fields a platform—a platform to our future.”