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
Allow Innovative Progressions To have a Tremendous Effect - 2Iran plans new restrictions in overhaul of Strait of Hormuz rules
- 3Figure out What Shift Differentials Mean for Your General Attendant Compensation
- 4What's the new 'Knives Out' mystery about? Everything to know about 'Wake Up Dead Man,' including who's in the cast and what the reviews say.
- 5Native Americans had dice and games of probability long before other cultures, study finds
- 15 Preposterous Cosplay Ensembles That Will Blow You Away
- Evidence of lost baptismal rite stage uncovered in Byzantine era cathedral near Sea of Galilee
- Home Plan Tips for Seniors
- The gay hockey show no one saw coming — and everyone is suddenly obsessed with
- It's been 20 years since MTV's golden couple split. These producers saw it all unravel.
- The new queen of country music has no scandals and no gimmicks — and just broke a record set by Taylor Swift
- Wellness Bits of knowledge Readily available: A Survey of \Following Wellbeing and Progress\ Wellness Wearables
- Self-sacrificing ants highlight the unity of their colony, say researchers
- What's The Friendliest City In The United Kingdom?
