TOKYO, Mar 17 (Pulse News Wire) – Stella Pharma Corporation (4888.T) announced today that it submitted an application to the Ministry of Health, Labour and Welfare for partial modification of manufacturing and marketing approval for its Boron Neutron Capture Therapy (BNCT) drug, BoroFaran (10B). The application targets recurrent meningiomas based on positive results from a Phase II clinical trial conducted at Osaka Medical College.
In the trial, patients treated with BNCT had a median progression-free survival time of 14.4 months (95% confidence interval: 7.9-26.4), compared to just 1.4 months (95% confidence interval: 1.0-9.0) for those receiving conventional treatments chosen by their doctors. The difference was statistically significant (p=0.0001, Log-rank test). Additionally, the overall response rate, defined as complete plus partial responses, was confirmed in 40% of the treatment group versus none in the control group. One-year and two-year survival rates were also favorable at 40% and 20%, respectively. Meningiomas are tumors arising from the meninges, protective membranes covering the brain and spinal cord.
While often benign, high-grade meningiomas can recur frequently and spread to other organs. In Japan, there are approximately 1,200 new cases annually, with around 1,500 total patients currently estimated. Due to limited effective treatments, the drug received orphan drug designation in September 2024 and priority review status in February 2026, potentially reducing regulatory review times. Stella Pharma continues to work towards providing BNCT as a new treatment option for cancer patients suffering from recurrent meningiomas. The company expects minimal impact on its fiscal year 2026 earnings from this submission.
🟢 Confidence: High AI-translated content.