By Kamal Choudhury and Christy Santhosh
(Reuters) -The U.S. Food and Drug Administration on Thursday approved Kura Oncology and Japanese partner Kyowa Kirin's once-daily pill, Komzifti, to treat a rare form of blood cancer that has returned or stopped responding to treatment.
The drug is approved for acute myeloid leukemia patients with an NPM1 mutation, a genetic change found in about 30% of cases.
Acute myeloid leukemia is an aggressive cancer of the blood and bone marrow.
Kura said the drug will be available within the next few business days at a price of $48,500 for a one-month supply.
With the approval, Kura's drug now competes with Syndax Pharmaceuticals' Revuforj, which was approved for the same indication by the FDA last month.
Komzifti’s approval comes with a boxed warning for differentiation syndrome and an additional warning for QTc interval prolongation, a delay in the heart’s electrical recovery after a beat, and potential harm to unborn babies.
A boxed warning is the U.S. Food and Drug Administration’s strongest alert for serious or life-threatening risks and appears prominently on a drug’s label to warn doctors and patients.
Revuforj carries a boxed warning for QTc interval prolongation, giving Kura “a significant competitive advantage,” according to Wedbush analysts.
Kura's Chief Medical Officer Mollie Leoni said the risk of QTc prolongation with Komzifti is low, adding it is “extraordinarily unlikely” to lead to a boxed warning.
The company said it is in dialogue with the FDA about potential steps post-approval that could help refine the labeling.
Under the terms of its collaboration with Kyowa, Kura is responsible for manufacturing Komzifti and will lead commercialization in the United States, while Kyowa handles commercial strategy and development outside the U.S.
Analysts, on average, expect Komzifti to have annual sales of $1.32 billion by 2031, according to LSEG data.
(Reporting by Kamal Choudhury and Christy Santhosh in Bengaluru; Editing by Shailesh Kuber and Tasim Zahid)
latest_posts
- 1
The Best Games On the planet - 2Instructions to Shield Your Gold Speculation from Possible Dangers: Fundamental Protections
- 3From Novice to Master: Dominating a Side interest
- 4FOX8 Meteorologist Charles Ewing makes his 2025-26 winter weather predictions!
- 5Experience Is standing by: History's Most noteworthy Travelers
- Vote In favor of Your Favored Language Interpretation Administration
- Tech for Wellbeing: Applications and Devices for a Better You
- The Most Compelling Books of the 10 years
- Reality TV star Spencer Pratt, who lost his home in Palisades Fire, is running for mayor of Los Angeles
- Merck sees over $5 billion opportunity in Cidara's experimental flu drug
- How do my eyes adjust to the dark and how long does it take?
- The Best Music Collections of the 10 years
- A definitive Manual for Picking Electric Vehicle: Decision in favor of Your Number one
- Study casts doubt on potential for life on Jupiter's moon Europa
