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Dr Kilburn on Findings From the FIREFLY-1 Trial of Tovorafenib in Pediatric Low-Grade Glioma

Lindsay Kilburn, MD, discusses key efficacy findings from the phase 2 FIREFLY-1 trial of the investigational type II RAF inhibitor tovorafenib (DAY101) in heavily pretreated pediatric patients with low-grade glioma.

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Tovorafenib Presents Opportunity for Tumor Reduction in Pediatric Low-Grade Glioma

Treatment with tovorafenib elicited encouraging and fast onset responses in heavily pretreated pediatric patients with low-grade glioma regardless of response assessment criteria, according to data from the phase 2 FIREFLY trial that were presented at the 2023 ASCO Annual Meeting.

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Day One Announces New FIREFLY-1 Data for Tovorafenib

Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to.

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Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma
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Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

Overall response rate of 67% and clinical benefit rate of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in October 2023 Conference. | June 4, 2023

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