US FDA Greenlights New Kura Oncology Drug

[kit_hung]

The US FDA has approved a new drug from Kura Oncology and Kyowa Kirin from Japan called Komzifti, a once-a-day pill for patients with acute myeloid leukemia with the NPM1 mutation, which is found in about 30 percent of cases.

Its price is not a joke, a one-month supply is about 48,500 dollars and now competes with Syndax's Revuforj, which was also approved last month.

Komzifti has been given a boxed warning about differentiation syndrome and also a warning of QTc interval prolongation as well as a risk to pregnancy, but Kura says the QTc risk is very low and does not reach the boxed warning.

Kura is doing the manufacturing and commercialization in the US while Kyowa is handling the market outside the US. Analysts predict sales could reach 1.32 billion dollars by 2031.

This is a major breakthrough and as the Chinese proverb says, small streams that gather together become a big river.


Source: Reuters

 

[gwolf666]

From my perspective, the FDA approval of Komzifti represents a significant advance in the treatment of acute myeloid leukemia, especially for patients with the NPM1 mutation, which affects a significant proportion of cases. However, the price of nearly $50,000 per month is very high and raises concerns about access for many patients who need this medication. While the warnings regarding differentiation syndrome and QTc are important, Kura Oncology seems confident that the risks are manageable, but they still raise concerns, particularly in cases of pregnancy. Competition with another recently approved drug also indicates a growing market with the potential for very high sales in the future. It is a remarkable advance, but it also reflects the difficulties of the current system, where the cost of innovative medicines remains a major barrier for most.