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
RFK Jr.'s diet guidelines emphasize red meat, full-fat dairy. How healthy are they? - 2World’s tallest bridge and biggest museum named ‘greatest places of 2026’
- 3Brazil's Bolsonaro to continue his sentence at home because of poor health
- 4Every year, she thanks the trooper for the arrest that led to her sobriety
- 5Philippines evacuates 3,000 villagers after volcano activity raises alert level
- How to watch 'A Charlie Brown Christmas' for free this weekend
- My Pioneering Excursion: Building a Startup
- Rediscovering Experience Through Excursions: Individual Travel Stories
- Influencers are selling a delusional fantasy of being postpartum. Why is it so easy to believe?
- IDF carried out mission to locate former hostage Avera Mengistu a day before Oct. 7
- Pilot captures jaw-dropping northern lights show from 36,000 feet (photos)
- Agios Pharma shares jump as US FDA expands approval for its blood disorder drug
- Astonishing interstellar comet captured in new images by NASA Mars missions
- Focus on Yourself: Wellbeing and Taking care of oneself Practices
