Daiichi Sankyo is now looking out for new horizons when it comes to its leukemia med Vanflyta, with Genesis Pharma signing to commercialize the drug across certain European countries.
This exclusive license, as well as the supply agreement goes on to cover 13 Central and Eastern European markets such as Bulgaria, the Czech Republic, Estonia, Hungary,
Croatia, Cyprus, Latvia, Romania, Slovakia, Slovenia, Lithuania, Malta, and Poland.
Daiichi is going to make as well as supply the med, whereas Genesis, the European pharma, is going to head up the medical affairs and market access along with the commercialization push across these countries as per the undisclosed financial terms, the release from the companies confirmed.
It is well to be noted that the leukemia med Vanflyta has been approved in Europe from 2023 as a treatment choice for adults having newly diagnosed FLT3-ITD-positive acute myeloid leukemia – AML in combination with standard induction as well as consolidation therapies, and also as a solo maintenance therapy after the consolidation chemo.
Almost 18,000 people get diagnosed with AML per year in Europe, as per Daiichi, having cancer-driving FLT3-ITD mutations, which occur in almost 25% to 30% of all the patients suffering from the disease.
Through combining their scientific expertise along with the robust regional footprint when it comes to Genesis Pharma, they look to speed up the access to Vanflyta for those patients having newly diagnosed FLT3-ITD-positive AML and would thereby help enhance outcomes within this high-risk population. confirmed head of Daiichi’s Europe and Canada oncology business division, Markus Kosch, M.D., in the release.
It is well to be noted that Vanflyta first got its approval in Japan around four years before the U.S. as well as European regulators signed off on the drug. In the phase 3 QuANTUM-First trial of Daiichi, leukemia med Vanflyta in its approved chemo combination went ahead and cut the risk of death by 22% as against standard chemotherapy alone within patients having newly diagnosed FLT3-ITD-positive acute myeloid leukemia.
That study has gone on to help win the FDA’s favor post a series of regulatory rebukes coming for the med within the U.S. When Vanflyta went on to eventually hit the market in the U.S., with a boxed warning for QT prolongation as well as other heart risks, it went on to become the first FLT3 inhibitor that was approved throughout the three phases, which were induction, consolidation, and maintenance of treating common blood cancer.
But still the company had its work cut out for it, as Rydapt from Novartis and Xospata from Astellas were, as a matter of fact, years ahead of Vanflyta due to their respective U.S. approvals in terms of FLT3-mutated AML.
Daiichi went ahead and recorded 4.5 billion Japanese yen, or $28.7 million, in Vanflyta sales in its 2024 financial year, whereas Astellas went ahead and lodged 68 billion Japanese yen, or $433 million, when it came to Xospata across the same period.
Novartis, on the other hand, does not include Rydapt-specific sales within its revenue reports; however, it is busy looking to widen its treatment’s reach because of a phase 2 pediatric study, which is going to read out in 2026, says a 2024 report.
