Investing.com -- Novocure Ltd (NASDAQ:NVCR) shares soared sharply after the announcement that the FDA had approved Optune Lua, a wearable device designed to treat certain types of lung cancer.
The stock surged more than 33% in premarket trading Wednesday, after closing the Tuesday session with a 10.7% gain at $17.78.
According to Novocure, the Optune Lua system is now approved for use in combination with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer (NSCLC) who have progressed following a platinum-based treatment.
The company highlighted that Phase 3 trial results marked the first significant improvement in median overall survival in more than eight years for this patient group.
“Novocure is committed to extending survival in some of the most aggressive and difficult to treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” said Asaf Danziger, CEO of Novocure.
“We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.”
Optune Lua works by delivering Tumor Treating Fields, which apply physical forces to the electrically charged components of dividing cancer cells, ultimately leading to cell death.
Novocure said the study's main goal was met, showing that patients treated with Optune Lua, along with a PD-1/PD-L1 inhibitor or docetaxel, lived significantly longer.
On average, these patients lived 3.3 months longer than those who only received the PD-1/PD-L1 inhibitor or docetaxel.
The group treated with Optune Lua had a median survival of 13.2 months, compared to 9.9 months for the group without Optune Lua.