AstraZeneca today announced that FDA has approved selumetinib for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA press release announcing the selumetinib approval is at https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-children-debilitating-and-disfiguring-rare-disease.
The SPRINT trial that was the basis for the selumetinib approval was an NCI/CTEP-sponsored clinical trial that led to selumetinib being available today for children with NF1-associated plexiform neurofibromas.
CTIS, Inc. is a contractor of NCI/CTEP that has developed and maintains CTEP-ESYS (CTEP Enterprise System), which was used to support the information and data needs during the conduct of this trial. CTEP-ESYS enables NCI/CTEP and the scientific community to focus on scientific opportunity, patient safety and finding better ways to treat, control and cure cancer.
CTIS is honoured to support NCI/CTEP in their distinctive role to bring this new medicine to children and adults in need of more effective therapies.