The U.S. Food and Drug Administration said on Wednesday that it has approved Jazz Pharmaceuticals’ (JAZZ.O), opens new tab drug to treat diffuse midline glioma, a rare and aggressive tumor, in adults and children aged one year and older.<\/p>\n
The approval expands Jazz\u2019s cancer drug portfolio beyond its existing treatments for certain blood and lung cancers.<\/p>\n
This is the first FDA-approved systemic therapy for diffuse midline glioma with a specific mutation that has progressed despite prior treatments, the agency said.<\/p>\n
The drug, Modeyso, is expected to become available in the U.S. in the coming weeks and is administered as a once-weekly oral capsule.<\/p>\n
Diffuse midline glioma (DMG) is a rare and aggressive brain tumor that primarily affects children and young adults. It develops in the brain\u2019s and spinal cord\u2019s midline structures, such as the brainstem, thalamus, and spinal cord.<\/p>\n
An estimated 3,940 people are living with this tumor in the United States, according to NIH data.<\/p>\n
The FDA decision was based on data from 50 patients in five clinical studies, showing that the drug helped shrink tumors in about 22% of cases. Among those who responded, the benefit lasted a median of just over 10 months.<\/p>\n
“We think it fits very well in terms of addressing a very high unmet need,” said Rob Iannone, Chief Medical Officer at Jazz Pharmaceuticals, ahead of the decision.<\/p>\n
Jazz Pharmaceuticals acquired the drug in March through its $935 million purchase of Chimerix.<\/p>\n","protected":false},"excerpt":{"rendered":"
The U.S. Food and Drug Administration said on Wednesday that it has approved Jazz Pharmaceuticals’ (JAZZ.O), opens new tab drug to treat diffuse midline glioma, a rare and aggressive tumor, in adults and children aged one year and older. The approval expands Jazz\u2019s cancer drug portfolio beyond its existing treatments for certain blood and lung […]<\/p>\n","protected":false},"author":2,"featured_media":1309,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[280],"class_list":{"0":"post-1308","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-food-and-drug","8":"tag-us-fda-approves-jazz-pharmas-drug-for-rare-brain-tumor"},"yoast_head":"\n