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AstraZeneca PLC (NASDAQ:AZN) announced Tuesday that the European Commission has approved Koselugo (selumetinib) for the treatment of symptomatic, inoperable plexiform neurofibromas in adults with neurofibromatosis type 1 (NF1). The approval follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on data from the KOMET Phase III trial.
The KOMET trial, which included 145 adult patients from 13 countries, found that Koselugo achieved a 20% objective response rate in tumor size reduction by cycle 16, compared to 5% with placebo. The trial’s primary endpoint was confirmed objective response rate, defined as the percentage of patients with either complete or partial response, with partial response being at least a 20% reduction in tumor volume. The safety profile observed in adults was consistent with previous findings in pediatric patients.
After 12 cycles of treatment, patients initially receiving placebo were switched to Koselugo, while those on Koselugo continued treatment for an additional 12 cycles. The study was presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The Lancet.
NF1 is a rare, progressive genetic disorder that can result in the development of non-malignant tumors called plexiform neurofibromas, which may lead to pain, disfigurement, and muscle weakness. Up to half of individuals with NF1 develop these tumors.
Koselugo is an oral MEK inhibitor previously approved in the US, EU, Japan, China, and other countries for certain pediatric NF1 patients. Recent approvals in Japan and other countries have extended its use to adults, with additional regulatory reviews ongoing.
AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada) have a strategic collaboration to co-develop and co-commercialize Koselugo.
This information is based on a press release statement filed with the US Securities and Exchange Commission.
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