Prioritized Review System for innovative medicines
Boron-based Drug SPM-011 for BNCT Designated for MHLW Prioritized Review
for innovative medicines “SAKIGAKE”
Boron-based drug “SPM-011” for BNCT for which Stella Pharma Corporation performs clinical development was designated by Ministry of Health, Labour and Welfare (MHLW) for “Prioritized Review System for innovative medicines ‘SAKIGAKE’” on April 21, 2017.
Intended indications and effectsRecurrent malignant gliomas
Unresectable locally recurrent head
and neck cancer and locally-advanced head
and neck cancer
(non-squamous cell carcinoma)
Name or trade name of applicantStella Pharma Corporation
The BNCT system (accelerator-based irradiation system) of Sumitomo Heavy Industries, Ltd. who jointly carries out the clinical study was assigned for the target item of the said system as a medical device on February 28, 2017, too.
“Prioritized Review System for innovative medicines ‘SAKIGAKE’” When an innovative new drug or medical device satisfies severity and other specified requirement of applicable diseases, the drug or the medical device whish MHLW evaluates and assigns is given priorities in consultation and review process for its approval by using this system, and the target NDA review period can be shortened to six months, one half of that required in ordinal review.