KOSELUGO™ (selumetinib) Approved In US For Pediatric Patients With Neurofibromatosis Type 1 Plexiform Neurofibromas
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Business Wire
First medicine approved to treat this rare and debilitating genetic condition WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approved the kinase inhibitor KOSELUGO™ (selumetinib) for the treatment of pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).The approval by the FDA was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase II SPRINT Stratum 1 trial coordinated by the NCI’s Center for Cancer Research, Pediatric Oncology Branch. This is the first regulatory approval anywhere in the world of a medicine for the treatment of NF1 PN.NF1 is a rare and debilitating genetic condition. Some 30-50% of patients with NF1 experience PN - tumors growing inside their nerve s
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