Stella Pharma said on 7 October 2026 that the health ministry has announced its application to add recurrent meningioma to the approved uses of Steboronine will be reviewed by the Second Committee on New Drugs of the Pharmaceutical Affairs Council. The company did not give a meeting date.
The application
The company filed the partial-change application for the boron neutron capture therapy (BNCT) drug in March 2026. The product is Steboronine IV infusion bag, 9000mg/300mL, and the intended indication is recurrent meningioma. Steboronine is already approved for unresectable locally advanced or locally recurrent head and neck cancer.
The notice says approval or rejection, and the final wording of the indication, will be decided after the committee's review and subsequent regulatory procedures. A committee review is therefore a step in the process, not an approval.
A wider label than the trial
The application rests on an investigator-initiated phase II randomised controlled trial run at Osaka Medical and Pharmaceutical University in recurrent high-grade meningioma. Stella Pharma is nonetheless seeking approval for "recurrent meningioma", which it describes as a broader patient group.
The company reports that progression-free survival, the primary endpoint, was 14.4 months in the BNCT group against 1.4 months in the comparison group, a statistically significant difference. The response rate was 27.3% in the BNCT group and none in the comparison group. One-year survival in the BNCT group was 100% and two-year survival 90.9%. The notice does not give the number of patients in each arm.
Market and company context
Stella Pharma estimates there are about 1,800 to 6,200 patients with recurrent meningioma in Japan, based on the health ministry's 2023 patient survey and other data, and says no drug therapy is approved for the condition in the country. Steboronine received orphan drug designation for recurrent meningioma in September 2024 and was treated as a priority review item in February 2026.
The company expects the effect on earnings for the year ending March 2027 to be minor. It says expanding indications is one of three pillars of its BNCT strategy, alongside more treatment sites and overseas expansion.