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
Instructions to Pick the Right Toothbrush for Your Teeth - 2Mom warns of Christmas gift hazard as daughter recovers in hospital
- 3Moldova says Russian drones violated airspace
- 4The risk of falling space junk hitting airplanes is on the rise, experts warn
- 56 Hints to Upgrade Your Appeal, In addition to Your Outlook
- The Best Games On the planet
- Humpback whale freed by rescuers in Baltic Sea has become stranded again
- Etymological Investigation Disclosed: A Survey of \Dominating New Tongues\ Language Learning Application
- A Manual for Pick High Evaluated Food Conveyance Administrations In Significant Urban communities For 2024
- Birds Will Flock To Your Birdbath When You Plant These Two Flowers Around It
- 7 Straightforward Moves toward Move Information from Your Old Cell phone to Your New One: A Thorough Aide
- See tonight’s solar storm unfold across the world
- December’s full moon is the last supermoon of the year. Here’s what to know
- New law puts familiar drinks, creams and gummies in legal limbo
