FDA's U.S. accepts new drug application for cancer drug selumetinib and grants priority review

recently, thehttp:// pharmaceuticalgiant AstraZeneca and partner Merck and Co announced that theof food anddrugs (http://)Administration (
FDA(http://had accepted and granted priority review to theapplication for a
new drug,
http://this NDA application for approval of selumetinib for the treatment of patients with symptomatic, surgically inoperaable clumps of neurofibromatoma (PN) pediatric patients with neurofibromatosis type 1 (NF1) associated with neurofibromatosis 3 years of ageIn February 2018, selumetinib was granted an orphan drug for the treatment of NF1 by the FDA and the europeanmedicines(http:// Authority (EMA) April 2019, seluminib was also qualified by the FDA for a breakthrough drug to treat NF1 　　About selumetinib
selumetinib is an oral, powerful, selective MEK1/2 inhibitor The NF1 gene encodes neurofibromin, which negatively regulates the RAS/MAPK pathway to help control cell growth, differentiation, and survival selumetinib potentially inhibits tumor growth by inhibiting meK enzymes in this pathway Currently, selumetinib is evaluating the potential for multiple types of tumors as a single therapy and a combination of other therapies 　　Selumetinib was discovered by Array BioPharma and AstraZeneca authorized the exclusive global rights to the compound in 2003 In July 2018, AstraZeneca and Mercado reached a strategic partnership for oncology to jointly develop and commercialize selumetinib and PARP inhibitorly Lynparza worldwide currently, the two sides are currently conducting Phase I/II clinical studies, SPRINT, to explore the potential benefits of selumetinib in non-surgical NF1-related plex osteofibromatoma (PN) pediatric patients 　　The study the NDA, based on the positive results of the SPRINT PHASE II Stratum 1 trial
(http:// , sponsored by the National Cancer Institute (NCI) Cancer Treatment Assessment Program (CTEP) data show that in nf1 pediatric patients 3 years and older with NF1 and symptomatic, surgically inable, the total remission rate (ORR) of selumetinib as a daily second oral monotherapy was 66% (n-33/50) ORR is defined as the proportion of patients who achieve complete or partial remission (tumor volume reduction of 20%)