Novocure's Optune, a device that uses electrical fields to disrupt tumor cell division, has received expanded FDA approval for the treatment of metastatic non-small cell lung cancer (NSCLC). This decision follows the Phase 3 LUNAR trial, which demonstrated a statistically significant, albeit modest, improvement in overall survival for patients whose cancer progressed after initial chemotherapy.
The LUNAR trial, the basis for this expanded approval, showed that Optune prolonged median overall survival by 3.3 months in patients with metastatic NSCLC. However, the trial data has faced scrutiny from some lung cancer experts. Concerns have been raised regarding the interpretability of the results, primarily because nearly 70% of the study participants had not received prior treatment with immune checkpoint inhibitors like Merck’s Keytruda, which is now a common first-line treatment for NSCLC.
The Optune device, also known as tumor treating fields (TTF), consists of four wired patches applied to the upper body with skin adhesive, surrounding the lungs. These patches connect to a battery-powered generator, creating an electrical field designed to interfere with tumor cell division while sparing healthy cells. Patients are instructed to wear the device for up to 18 hours daily. The device was previously approved for certain types of brain tumors and will be marketed as Optune Lua for lung cancer.
In other news, FDA Commissioner Robert Califf has lauded GLP-1 treatments as a "breakthrough class of drugs," noting their potential not only for weight loss but also for improving cardiovascular health and treating MASH and addictive behaviors. Califf also reflected on the societal factors contributing to obesity rates in the U.S., questioning the long-term sustainability of relying on expensive medications to counteract the effects of manipulated food and advertising.
Mark Cuban, entrepreneur and owner of Cost Plus Drugs, revealed that Martin Shkreli's actions in radically raising the price of Daraprim inspired him to enter the pharmaceutical industry. Cuban's company aims to increase transparency in drug pricing to combat the opacity he observed in the pharmaceutical market.
