Alyscon and Mersa jointly developed the research drug selumetinib has been awarded an FDA-issued breakthrough therapy
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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incidence is about 1 case per 34,000 newborns, neurofibromatosis type 1 (NF1), a rare, incurable genetic diseaseNF1 is caused by a mutation in the NF1 gene ofsynthetic(http://neurofibrominThis mutation disrupts the RAS/MAPK signaling pathway (RAS-RAF-MEK-ERK), which in turn leads to tumor growthtoday, AstraZeneca and Mersadon (MSD) announced that their joint development of thedrug(http://Selumetinib has been recognized as a breakthrough therapy issued by theFDA(http://for the treatment of neurofibromatosis patients over the age of 3 who exhibit symptoms and/or undergo surgeryMEK is a key protein kinase in the RAS/MAPK signaling pathwaySelumetinib selectively inhibits MEK1 and MEK2, thus restoring normal signaling pathways for disorderly signaling, which in turn relieves the condition of CHILDREN with NF1Previously, selumetinib was approved by the FDA and EMA for the treatment of NF1This breakthrough therapy designation is based on the effectiveness and safety of the treatment NF1-related PN demonstrated by selumetinib in the Phase 2 SPRINT Trial (http:// in Phase1 and 2 trials, 71% and 72% of patients, respectively, experienced partial remission, and their tumor volume decreased by more than 20%, which showed the repeatability of the efficacy of selumetinib In addition, the majority of patients had more than half a year of clinical remission by 2018
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