KOSELUGO® (selumetinib) Approved by FDA for Pediatric Patients Two Years and Older With Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
First Medicine Approved to Treat This Rare and Debilitating Condition KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. 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 FDA approval is based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase 2 SPRINT Stratum 1 trial coordinated by the NCI’s Center for Cancer Research, Pediatric Oncology Branch. This is the first regulatory approval of a medicine for the treatment of NF1 PN, a rare and debilitating genetic condition.Results showed an overall response rate (ORR) of 66% [95% CI: 51, 79] in pediatric patients with NF1 and symptomatic, inoperable PN (n=33/50 pati
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