AstraZeneca PLC announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved the oral MEK inhibitor Koselugo (selumetinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).
The approval is based on results from the KOMET Phase III clinical trial, which demonstrated an overall response rate of 20% in tumor size reduction among adult patients.
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