Innovative drugs with prioritized review
Stella Pharma’s BNCT drug SPM-011
designated by the Japanese government for prioritized review
On April 21, 2017, Stella Pharma’s drug SPM-011 was accepted for priority review by the Japanese Ministry of Health, Labour and Welfare in the SAKIGAKE system for innovative medicines. SPM-011 was developed for BNCT to fight cancer.
Intended indications and effects
- Recurrent malignant gliomas
- Unresectable locally recurrent head and neck cancer
- Locally-advanced head and neck cancer (non-squamous cell carcinoma)
Name or trade name of applicantStella Pharma Corporation
In addition to SPM-011, the accelerator-based neutron system developed by our clinical trial collaborator, Sumitomo Heavy Industries, was also accepted for review in the SAKIGAKE system.
What is the SAKIGAKE system of prioritized review?
Under certain conditions, an innovative drug or medical device developed for medical conditions of particular severity or urgency may be given priority for government consultation and review, reducing the approval time from one year to six months. SAKIGAKE reviews are approved by the Ministry of Health, Labour and Welfare.