FDA accepts Novocure PMA application for TTFields therapy in NSCLC

Novocure announced that its Premarket Approval PMA application seeking approval for the use of Tumor Treating Fields TTFields therapy together with standard systemic therapies for the treatment of non-small cell lung cancer NSCLC , following progression on or after platinum-based therapy, has been accepted for filing by the U.S. Food and Drug Administration FDA . “We are thrilled to announce the FDA has accepted our PMA application for review of the LUNAR data in NSCLC,” said Asaf Danziger, Novocure’s Chief Executive Officer. “This significant milestone brings us one step closer to treating patients seeking treatment for NSCLC, post-platinum, for which very few effective non-toxic options exist today. I would like to thank our investigators and patients, as well as our Novocure colleagues, for their dedication in pursuit of bringing our novel therapy to thousands of patients in need.” The PMA application for LUNAR was submitted with a filing date of December 15, 2023, and is now under substantive review by the FDA. Novocure expects to receive a regulatory decision from FDA in second half 2024.