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 Expand Your Advantages from an Open Record Reward - 2Progress Over Perfection: Lessons From Garment Factories Fighting Heat Stress
- 3Yasser Abu Shabab's killing raises questions about Israel's militia strategy in Gaza
- 4Massive supernova explosion may have created a binary black hole
- 5Supportive Tips On Home loans For First-Time Home Purchasers
- Everything to know about NASA's moon mission launching this week
- Jupiter and the moon take a sunset stroll on March 26. Here's how to see it
- Must-See Attractions in Washington, D.C.
- Plane Passenger Allegedly Includes ‘Bomb Threat’ in Hotspot Network Name, Forces Flight to Make Emergency Landing
- ‘Slender Man’ attacker back in custody. What we know about Morgan Geyser's disappearance and what happens next.
- Help Your Business with Master Web based Promoting Arrangements
- Evaluated Smartwatches for Wellness Devotees
- 6 Agreeable Earphones To Wear
- Find Your Internal Culinary expert: Cooking Strategies and Recipes
