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
SpaceX rocket launches 140 satellites into orbit on Transporter-15, aces landing at sea (video) - 2Two reportedly killed as Israel attacks Hezbollah targets in Lebanon
- 3Chinese fossils reveal a primordial burst of animal evolution
- 4The most effective method to Pick the Right Volvo XC40 Trim for Your Way of life
- 5San Francisco sues 10 companies that make ultraprocessed food
- ‘Democratizing space’ is more than just adding new players – it comes with questions around sustainability and sovereignty
- Pfizer in $41.5 million settlement with Texas over ADHD drug for children
- Find the Captivating Professional flowerbeds of the US
- College students are now slightly less likely to experience severe depression, research shows – but the mental health crisis is far from over
- The Benefits of Effective money management for Your Youngsters' Future Monetary Prosperity
- The 10 Most Compelling Forerunners in Innovation
- Flights canceled at 40 U.S. airports: Follow live updates as FAA cuts to air traffic take effect amid government shutdown
- Islamic State group militants claim capture and execution of a Nigerian brigadier general
- A Couple of Modest Guitars for 2024
