Novocure (NASDAQ:NVCR) saw its shares jump sharply in after-hours trading on Wednesday following U.S. Food and Drug Administration approval of its Optune Pax system for locally advanced pancreatic cancer.
The approval permits the wearable device to be administered in combination with the chemotherapy agents gemcitabine and nab-paclitaxel. Optune Pax delivers Tumor Treating Fields (TTFields) - alternating electric fields intended to interfere with cancer cell division and promote cancer cell death while aiming to avoid major harm to healthy tissue.
On the market front, the stock surged more than 30% to $13.80 by 20:19 ET, after earlier climbing in excess of 50% during the initial post-market session.
Data supporting approval
The FDA decision was based on findings from the Phase 3 PANOVA-3 trial, which enrolled 571 patients. According to the trial results, the study demonstrated a significant delay in the progression of pain and an improvement in one-year survival rates for patients receiving the treatment regimen that included Optune Pax.
The safety data reported in the trial were described as broadly comparable between the two treatment arms evaluated in the study.
Market and clinical context
The FDA clearance and the clinical outcomes highlighted by PANOVA-3 translated immediately into stock-market movement, with pronounced volatility in the post-market session. The clinical readouts cited - delay in pain progression and improved one-year survival - were central to the regulator's decision, with safety signals characterized as broadly similar across arms in the trial.
While the approval covers a specific patient population - locally advanced pancreatic cancer - the announcement intersected both the medtech and oncology pharmaceutical sectors, and prompted a sizeable investor reaction in Novocure's shares.
What we know
- Optune Pax is cleared to be used alongside gemcitabine and nab-paclitaxel for locally advanced pancreatic cancer.
- The approval is founded on Phase 3 PANOVA-3 results from 571 enrolled patients.
- The trial reported delayed pain progression, improved one-year survival rates, and safety findings broadly comparable between treatment arms.