Japan to review GSK's Blenrep drug application
Japan's health ministry has accepted for review a new drug application (NDA) for 's Blenrep blood cancer treatment, marking the third major regulatory filing acceptance for the drug.
This follows marketing authorisation application acceptance by the European Medicines Agency in July and by the Medicines and Healthcare products Regulatory Agency in the UK earlier this month.
Japan's Ministry of Health, Labour and Welfare has also granted Blenrep orphan drug designation, which GSK said "reflects the high unmet medical need and ensures priority NDA review in multiple myeloma".
The regulatory submission was supported by results from the DREAMM-7 and DREAMM-8 phase III clinical trials, which evaluated Blenrep combined with BorDex or PomDex for the treatment of relapsed or refractory multiple myeloma, a type of bone marrow cancer.
The number of patients diagnosed with multiple myeloma in Japan has increased continuously over the past five decades, with more than 7,200 new cases reported each year..
"We are committed to working with health authorities worldwide to advance Blenrep along regulatory pathways so we can bring these additional treatment options to patients as quickly as possible," said Hesham Abdullah, senior vice president and global head of oncology at GSK's R&D division.
On Friday, China's health authority granted Blenrep with a so-called 'Breakthrough Therapy Designation', which is designed to speed up development of investigational drugs.
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