- Daiichi Sankyo’s Vanflyta receives FDA approval for treating aggressive blood cancer, AML, in newly diagnosed patients with FLT3-ITD gene mutations.
- Vanflyta becomes the first drug in the US approved across all phases of AML treatment, presenting competition to rival drugs from Novartis and Astellas.
Daiichi Sankyo has achieved a major milestone with the FDA approval of their drug, Vanflyta, for the treatment of newly diagnosed patients with acute myeloid leukemia (AML), a highly aggressive form of blood cancer. This groundbreaking approval makes Vanflyta the first-ever drug in the US to be specifically approved for AML patients with FLT3-ITD mutations, which are associated with increased risks of relapse and shorter survival rates.
Vanflyta, which had already gained approval in Japan, showcased impressive results in its clinical trials, exhibiting a remarkable 22% reduction in the risk of death when compared to standard chemotherapy alone, as evidenced in the QuANTUM-First trial. An additional advantage is that the drug is authorized for use across all phases of AML treatment, including induction, consolidation, and maintenance therapy, thereby providing a competitive edge over rival medications like Novartis’ Rydapt and Astellas’ Xospata.
Priced at $546 per tablet for wholesale acquisition, Vanflyta is poised to make a significant impact on the market, presenting formidable competition to its counterparts. Capitalizing on this achievement and the drug’s potential, Daiichi Sankyo aims to generate an estimated $500 million in sales over the next decade, leveraging their expanding oncology portfolio.