Jazz Pharmaceuticals' Modeyso™ Gains FDA Accelerated Approval for Treatment of H3 K27M-Mutant Diffuse Glioma
Reuters
Sep 09
Jazz Pharmaceuticals' Modeyso™ Gains FDA Accelerated Approval for Treatment of H3 K27M-Mutant Diffuse Glioma
Jazz Pharmaceuticals plc has announced that its drug, Modeyso™ (dordaviprone), has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients, aged 1 year and older, with diffuse midline glioma harboring an H3 K27M mutation and progressive disease following prior therapy. This approval, announced on September 9, 2025, marks Modeyso as the first treatment option for this ultra-rare and aggressive brain tumor in the United States. The National Comprehensive Cancer Network® (NCCN®) has also included Modeyso in its Clinical Practice Guidelines in Oncology as a category 2A single-agent treatment option for these patients. Continued approval may be contingent upon the results of the ongoing Phase 3 ACTION confirmatory trial.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF68074) on September 09, 2025, and is solely responsible for the information contained therein.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.