AstraZeneca Selumetinib capsules submit clinical applications in China
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, it was revealed that AstraZeneca's Selumetinib capsule suised clinical applications in the countrySelumetinib filed an application fornew drug(http://to treat patients with type 1 neurofibromatosis (NF1) who are unable to undergo surgical treatment and have been granted priority review by the FDA on November 14 in the u.S(http://Selumetinib is a MEK 1/2 inhibitor, a key protein kinase in the RAS/MAPK signaling pathway, and the incidence of NF1 is precisely due to the NF1 gene mutation that disrupts tumor growth caused by the RAS/MAPK signaling pathwaySelumetinib was awarded the breakthrough treatment law by the FDA in April 2019 and was awarded the orphan drug in February 2018Under a licensing agreement, AstraZeneca and MSD are jointly developing and commercializing selumetinib globallyA Phase II clinical study codenamed SPRINT showed that selumetinib single-drug therapy enabled the objective remission rate (ORR) of NF1 patients to reach 66%ORR is defined as a complete tumor remission or a tumor size reduction of more than 20%AstraZeneca/MSD is based on the results of this clinicaltrial(http://submitted to the FDA, the FDA gave the PDUFA date 2020 Q2, if approved, will be the first FDA-approved oral MEK1/2 inhibitor for the treatment of NF1
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