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
Smooth countdown continues for Artemis II moon mission - 2Olivia Rodrigo announces 3rd album, 'You Seem Pretty Sad for a Girl So in Love,' set to debut in June
- 3Investigating Free Cell Phones: What You Really want to Be aware
- 4What's Your #1 Pizza Beating Mix?
- 5Taco Bell debuts its Baja Blast pie, and the reactions may surprise you
- Avoid Slam: Clearing the Street for the Eventual fate of Standard Size Trucks
- Where You Could Sleep With Snorlax in Japan, From MIMARU’s Pokémon Rooms to Grand Hyatt Tokyo’s Limited Pokémon Suite
- The Best Traditional Music Arrangers in History
- Comet C/2025 K1 (ATLAS) breaks apart in incredible telescope photos
- Scientists may be overestimating the amount of microplastics in the environment – and the culprit is lab gloves
- Nordic people know how to beat the winter blues. Here's how to find light in the darkest months
- Kelsey Grammer on having a new baby at 70: 'You're just more available now'
- How much should a kid's birthday party cost? One mom spent $190 for pizza and ice cream at a park. Another paid $2K for a playspace and goodie bags.
- HR exec caught on Coldplay 'kiss cam' with boss finally breaks her silence: 'I made a bad decision and had a couple of High Noons'
