AstraZeneca (AZN) received the US Food and Drug Administration's approval for selumetinib to treat adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas, the agency said Wednesday.
A trial showed a 20% confirmed overall response rate in the selumetinib arm versus 5% for placebo, the agency said.
Safety findings were consistent with the known selumetinib safety profile, the FDA said.
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