The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
The FDA has approved Novocure's Optune Pax device for locally advanced pancreatic cancer, marking the first new treatment for this patient group in decades. A trial of 571 patients showed a two-month improvement in overall survival when combined with chemotherapy.
The FDA approved Novocure's Optune Pax device for locally advanced pancreatic cancer treatment alongside chemotherapy, marking the first new treatment option in this indication since 1996. Phase III trial data showed statistically significant survival improvement.