Why Is Cancer Focused Novocure Stock Trading Higher Today?

Novocure Ltd NVCR announced that its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for non-small cell lung cancer (NSCLC), following progression on or after platinum-based therapy, has been accepted for filing by the FDA.

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 the FDA in the second half of 2024.

Tumor Treating Fields use electric fields to disrupt cell division. These Fields do not stimulate or heat tissue and target dividing cancer cells of a specific size, thus causing minimal damage to healthy cells.

LUNAR tested the safety and effectiveness of TTFields therapy when used with either an immune checkpoint inhibitor (ICI) or docetaxel for metastatic NSCLC following progression on or after platinum-based therapy. 

Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated a 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.

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.

Price Action: NVCR shares are up 21.70% at $15.12 on the last check Thursday.