After over a decade in development, Vanflyta scored FDA approval in newly diagnosed FLT3-ITD acute myeloid leukemia, where Novartis FLT3 inhibitor Rydapt has been on the market for years.
It took several years, but Daiichi Sankyo Co., Ltd.’s Vanflyta (quizartinib) has finally crossed the finish line in the US, with the Food and Drug Administration approving the drug, giving it a first-line acute myeloid leukemia (AML) label that sets it up as a competitor for Novartis AG’s Rydapt (midostaurin).
The FDA cleared Vanflyta on 20 July – just before its 24 July action date – in combination with cytarabine...
The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.
The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
