Shots:
- The US FDA has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)
- Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries, incl. North America, South America, Europe, Asia & Australia
- The study met its 1EP, showing an ORR of 20% (14/71) vs 5% (4/74) by cycle 16, with 86% pts on Koselugo having an observed DoR of at least 6mos.; PBO pts switched to Koselugo after 12 cycles, while treated pts continued for 12 additional cycles. Results were presented at ASCO’25 & published in The Lancet
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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