Japan's Daiichi Sankyo gets US FDA nod for blood cancer treatment
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[July 21, 2023]
By Sriparna Roy
(Reuters) -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.
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Signage is seen outside of the Food and
Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.,
August 29, 2020. REUTERS/Andrew Kelly/File Photo
![](http://archives.lincolndailynews.com/2015/May/02/images/ads/current/guzzardo_lda022609.png) "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.
Patients with the FLT3-ITD mutation, which is targeted by Daiichi's
drug, are at an increased risk of relapse and shorter survival.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shailesh Kuber
and Shounak Dasgupta)
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