ziftomenib

FDA Drug Profile — Komzifti

ziftomenib is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Komzifti. Available dosage form: capsule.

Drug Details

Generic Name
ziftomenib
Brand Names
Komzifti
Application Number
NDA220305
Sponsor
Kura Oncology, Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
ZIFTOMENIB

Indications and Usage

1 INDICATIONS AND USAGE KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14 )] . KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options. ( 1 )