Daiichi Sankyo is eying new horizons for its leukemia med Vanflyta, with Genesis Pharma signing on to commercialize the drug in certain European countries.
The exclusive license and supply agreement covers 13 markets across central and eastern Europe: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia.
Daiichi will make and supply the med, while European pharma Genesis will head up medical affairs, market access and commercialization efforts in these countries under undisclosed financial terms, the companies said in a release.
Vanflyta has been approved in Europe since 2023 as a treatment option for adults with newly diagnosed FLT3-ITD-positive acute myeloid leukemia (AML) in combination with standard induction and consolidation therapies, plus as a solo maintenance therapy following consolidation chemo.
Approximately 18,000 people are diagnosed with AML annually in Europe, according to Daiichi, with cancer-driving FLT3-ITD mutations occurring in about 25% to 30% of all patients with the disease.
“By combining our scientific expertise with the strong regional footprint of Genesis Pharma, we aim to accelerate access to Vanflyta for patients with newly-diagnosed FLT3-ITD positive AML and ultimately help improve outcomes in this high-risk population,” Markus Kosch, M.D., head of Daiichi’s Europe and Canada oncology business division, said in the release.
Vanflyta was first approved in Japan four years before U.S. and European regulators signed off on the drug. In Daiichi’s phase 3 QuANTUM-First trial, Vanflyta in its approved chemo combination slashed the risk of death by 22% versus standard chemotherapy alone in patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia.
That study helped win the FDA’s favor after a series of regulatory rebukes for the med in the U.S. When Vanflyta eventually hit the market in the U.S., albeit with a boxed warning for QT prolongation and other heart risks, it became the first FLT3 inhibitor approved across three phases (induction, consolidation and maintenance) of treating the common blood cancer.
Still, the company had its work cut out for it, as Novartis’ Rydapt and Astellas’ Xospata were years ahead of Vanflyta with their respective U.S. approvals for FLT3-mutated AML. Daiichi recorded 4.5 billion Japanese yen ($28.7 million) in Vanflyta sales during its 2024 financial year, while Astellas logged 68 billion Japanese yen ($433 million) for Xospata over the same period.
Novartis, meanwhile, doesn’t include Rydapt-specific sales in its revenue reports but is busy looking to expand its treatment's reach with a phase 2 pediatric study that will read out in 2026, according to a 2024 report.