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
Lego's $650 Pokémon set is already sold out as demand, preorders surge - 2Iran war pushes Germany's deficit to 4.2% as growth outlook is cut by 50%
- 3How mountain terraces have helped Indigenous peoples live with climate uncertainty
- 4What's your biological age? Experts explain the benefits and risks of at-home tests
- 5The Response Uncovered: Disentangling the Secrets of the Universe
- Remain Cool and Solid: Top Summer Food sources for 2024
- This Overlooked Predator Is Running Out of Time—Why Conservationists Are Racing to Save the Striped Hyena
- AI is providing emotional support for employees – but is it a valuable tool or privacy threat?
- Vote In favor of Your Favored Sort Of Dress
- Terminal cancer diagnosis announced by JFK's granddaughter
- Vote in favor of your Number one natural product
- Rick Steves Doesn't Want You Overlooking This Food Spot While In France
- Pick Your Favored sort of cooking
- 5 Great High-Mileage Electric Vehicles Of 2024
