On January 18, 2024 Novocure (NASDAQ: NVCR) reported 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) (Press release, NovoCure, JAN 18, 2024, View Source [SID1234639346]).
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"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.
About LUNAR
LUNAR tested the safety and effectiveness of TTFields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median overall survival (OS) of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.
About NSCLC
Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, docetaxel, immune checkpoint inhibitors or pemetrexed.