Japan’s Daiichi Sankyo gets US FDA nod for blood cancer treatment

Daiichi Sankyo said the U.S. health regulator has approved its drug for treating newly diagnosed patients suffering from an aggressive type of blood cancer, pitting the treatment against those from rivals Novartis and Astellas.

The drug, which is already approved in Japan has faced a long path to the U.S. market, with the Food and Drug Administration (FDA) declining to approve it in 2019 in a different set of acute myeloid leukemia (AML) patients and then extending its review by three months earlier this year.

The treatment, branded as Vanflyta, got FDA’s nod to treat adult patients with a specific gene mutation associated with increased risk of relapse in patients with 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 on Thursday.

Astellas’ oral tablet Xospata’s wholesale acquisition cost is $22,500 for a month’s supply, while the list price of Novartis’ Rydapt is $7,495 for a 14-day treatment and $14,990 for a 28-day treatment.

Daiichi has been focusing on building its oncology portfolio to help drive growth.

“It’s the biggest growth area of Daiichi Sankyo, and we’re off to a really, really strong start,” Ken Keller, head of the company’s global oncology business said ahead of the approval.

Jefferies analyst Naoya Miura expects the drug to make $500 million in sales after 10 years.

AML is one of the most common types of blood cancer in adults. Mutations in the FLT3 gene, which plays a role in helping white blood cells grow, can cause excess growth of these cells and lead to an aggressive form of leukemia.