A Prescription Drug User Fee Act target date of November 30, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...
Launched KOMZIFTI™ (ziftomenib), first and only once-daily, oral menin inhibitor approved for adults with R/R NPM1-mutated AML – – $2.1 million ...
The combination therapy, referred to as DAGO+m, yielded a 91% overall response rate and a promising 2-year overall survival ...
Revuforj is approved for relapsed/refractory AML with NPM1 mutation in patients aged one year and older, based on AUGMENT-101 trial results. The drug inhibits menin's interaction with KMT2A, slowing ...
Kura Oncology and Kyowa Kirin announce FDA acceptance of ziftomenib NDA for relapsed/refractory AML, targeting a November 2025 decision. Kura Oncology and Kyowa Kirin announced that the FDA has ...
SAN DIEGO — Allogeneic stem cell transplant is associated with a significant survival benefit in patients with NPM1-mutated acute myeloid leukemia (AML) who are in their first complete remission and ...
Revumenib demonstrates significant efficacy in R/R AML with NPM1m, KMT2Ar, and NUP98r, showing high response rates and tolerability. The AUGMENT-101 study reports a 26% CR/CRh rate in NPM1-mutated AML ...
HOUSTON -- Complete response (CR) rates in relapsed/refractory NPM1-mutated acute myeloid leukemia (AML) doubled historical rates in a preliminary study of an investigational menin inhibitor. A pooled ...
Adding the menin inhibitor revumenib (Revuforj) to azacitidine and venetoclax (Venclexta) seemed to benefit older adults with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia ...
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