WASHINGTON – The US health regulator has approved Japan-based Daiichi Sankyo Co’s therapy for newly diagnosed patients with an aggressive type of blood cancer, the company said, pitting it against rival drugs from Novartis and Astellas Pharma.
The therapy, branded as Vanflyta, gained the Food and Drug Administration’s (FDA) nod to treat adult patients with a specific gene mutation associated with increased risk of relapse in patients with acute myeloid leukemia (AML), a type of blood and bone marrow cancer.
The wholesale acquisition cost of the treatment is $546 per tablet for both the 17.7 mg and 26.5 mg dose, the company said in an emailed statement to Reuters.
Vanflyta has been approved in combination with chemotherapy, and as maintenance monotherapy after consolidation chemotherapy, the company said.
The therapy has faced a long path to the market, with the FDA declining to approve it in 2019 in a different set of AML patients and then extending its review by three months earlier this year.
Daiichi will now compete with Novartis’ Rydapt, which was approved in 2017 as an initial treatment for AML, and Astellas’ oral tablet Xospata, which was approved a year later for patients with AML with a FLT3 mutation, whose cancer had relapsed or proved treatment-resistant.
