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AstraZeneca : Selumetinib Granted Orphan Drug Designation In Japan For Neurofibromatosis Type 1

AstraZeneca (AZN.L,AZN) said that selumetinib has been granted orphan drug designation in Japan for the treatment of neurofibromatosis type 1 or NF1, a rare and debilitating genetic disease.

Selumetinib is co-developed and co-commercialised with Merck & Co.

The National Cancer Institute Cancer Therapy Evaluation Program-sponsored Phase I/II SPRINT Stratum 1 trial showed an overall response rate of 66% in paediatric patients with NF1 PN when treated with selumetinib as a twice-daily oral monotherapy.

Overall response rate is defined as the percentage of patients with confirmed complete or partial response of at least 20% reduction in tumour volume.

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