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Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs

Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
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United statesAcceleron pharmaSusan pandyaIslam hassanLori steelmanOncology at servier pharmaceuticalsScientific researchEuropean commissionAgios pharmaceuticalsServier pharmaceuticals seniorLimitations in existingNovel therapeuticServier pharmaceuticals senior directorClinical science lori steelmanSenior medical directorPatient experience at the center

FDA accepts Servier s NDA review for glioma treatment

The US Food and Drug Administration (FDA) has accepted Servier’s NDA filing and priority review for vorasidenib for IDH-mutant diffuse glioma.

Susan pandyaServier cancer metabolism global development oncologyEuropean medicines agencyEuropean commissionPrescription drug user fee actCancer metabolism global development oncology

FDA Accepts Application, Grants Priority Review to Vorasidenib for IDH-Mutant Diffuse Glioma

If vorasidenib receives full approval, it would be a first-in-class target therapy to treat individuals with IDH-mutant gliomas.

Susan pandyaClaude bertrandEuropean medicine agencyResearch developmentNew drug applicationPriority reviewPrescription drug unser fee actCancer metabolism global development oncologyHazard ratioConfidence intervalExecutive vice presidentChief scientific officer

FDA and EMA Accept Regulatory Submissions for Vorasidenib for IDH-Mutant Diffuse Glioma

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

Claude bertrandSusan pandyaEuropean commissionCancer metabolism global development oncology immunoMeeting of the society for neuroEuropean medicines agencyResearch developmentMarketing authorization applicationNew england journalCancer metabolism global development oncologyPrescription drug user fee actIdh mutant diffuse glioma

Vorasidenib Under Review for Isocitrate Dehydrogenase-Mutant Diffuse Glioma

The NDA is supported by results from the phase 3 INDIGO trial, which included patients 12 years of age and older with residual or recurrent grade 2 glioma with confirmed IDH1 or IDH2 gene mutation who had undergone surgery as their only treatment.

Susan pandyaDrug administrationPriority reviewNew drug applicationCancer metabolism global development oncologyPrescription drug user fee act