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
She's been a Bond girl and a mutant. Now she's grappling with Hollywood's obsession with 'eternal youth.' - 2Feeling wonder every day improves our health. Here’s how to do it.
- 3Former school bus aide pleads guilty to assaulting 3 autistic students in Colorado
- 4Nigeria warns its citizens in South Africa to be cautious after march turns violent
- 56 Trail blazing Bicycles for Rough terrain Undertakings
- Ukrainian drones hit all three Baltic States − did Russia redirect them?
- Moon milestones: A rundown of Artemis 2's many spaceflight firsts
- More parents refusing this shot that prevents serious bleeding at birth
- NASA releases new ‘Earthset’ and eclipse images taken during historic flyby of the moon
- Dominating the Art of Composing: Creator Bits of knowledge
- Inconceivable Spots To Stargaze All over The Planet
- Melodic Event: A Survey of \Energies and Exhibitions Assessed\ Live concert
- Huge Iranian missile fragments, intercepted by air defenses, lay scattered across Israel, West Bank
- Becoming Familiar with an Unknown dialect: My Language Learning Excursion
