Stella Pharma said the Second Committee on New Drugs of Japan's Pharmaceutical Affairs Council has concluded that its boron neutron capture therapy (BNCT) drug Steboronine can be approved for recurrent meningioma. The company said it received notice of the conclusion. Formal manufacturing and marketing approval has not yet been granted.
The company expects approval after "prescribed administrative procedures". It filed the application for a partial change to the approved indications in March 2026. Its disclosure gives no date for the final step. Earlier Tokyo Brief coverage is at Earlier Tokyo Brief coverage.
What the trial showed
The application rests on an investigator-initiated Phase II randomized trial run at Osaka Medical and Pharmaceutical University in recurrent high-grade meningioma. Stella Pharma says the study was supported by the Japan Agency for Medical Research and Development (AMED).
On the primary endpoint, progression-free survival, the BNCT group reached 14.4 months against 1.4 months for the comparator group. Stella Pharma says the difference was statistically significant. The response rate, a secondary endpoint, was 27.3% in the treatment group, and the company says no responses were seen in the comparator group. It also reports one-year survival of 100% and two-year survival of 90.9% in the treatment group. These figures are the company's account of the trial. Its release gives no sample sizes, so the weight of the results cannot be judged from it.
Regulatory path and commercial effect
Steboronine received orphan drug designation for recurrent meningioma in September 2024 and was evaluated as a priority review item in February 2026. It is already approved for unresectable locally advanced or locally recurrent head and neck cancer. Stella Pharma says Japan has no approved drug therapy for recurrent meningioma.
The company calls the result a step in the indication-expansion pillar of its growth strategy, alongside more treatment sites and overseas expansion. It expects only a slight effect on earnings for the year to March 2027, and a contribution to BNCT business growth over the medium to long term.