ARTICLE | Regulation
FDA’s Ojemda approval marks Day One’s transition to commercial company
No black box warning and a broad label for the pediatric brain cancer therapy
April 25, 2024 12:35 AM UTC
Six years into the organization’s lifetime, Day One is becoming a commercial company after FDA approved Ojemda to treat pediatric low-grade glioma.
The agency granted accelerated approval to Ojemda tovorafenib from Day One Biopharmaceuticals Inc. (NASDAQ:DAWN) on Tuesday afternoon, a week before its April 30 PDUFA date. The pan-RAF inhibitor is approved to treat patients 6 months of age and older with relapsed or refractory disease with either a BRAF fusion or rearrangement, or a BRAF V600 mutation...