{"id":913888,"date":"2025-11-25T17:26:46","date_gmt":"2025-11-25T22:26:46","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/komzifti-ziftomenib-added-to-national-comprehensive-cancer-network-nccn-guidelines-for-acute-myeloid-leukemia-aml\/"},"modified":"2025-11-25T17:26:46","modified_gmt":"2025-11-25T22:26:46","slug":"komzifti-ziftomenib-added-to-national-comprehensive-cancer-network-nccn-guidelines-for-acute-myeloid-leukemia-aml","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/komzifti-ziftomenib-added-to-national-comprehensive-cancer-network-nccn-guidelines-for-acute-myeloid-leukemia-aml\/","title":{"rendered":"KOMZIFTI\u2122 (ziftomenib) Added to National Comprehensive Cancer Network\u00ae (NCCN) Guidelines for Acute Myeloid Leukemia (AML)"},"content":{"rendered":"

\nKOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R\/R NPM1-mutated AML, is now commercially available in the United States
\n<\/h2>\n
\n

SAN DIEGO and TOKYO, Nov. 25, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA, \u201cKura\u201d) and Kyowa Kirin Co., Ltd. (TSE: 4151, \u201cKyowa Kirin\u201d) today announced KOMZIFTI\u2122 (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1<\/em> mutation, has been included in the National Comprehensive Cancer Network\u00ae<\/sup> (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) as a Category 2A recommended treatment option for adults with relapsed\/refractory AML with NPM1<\/em> mutation.<\/p>\n

KOMZIFTI received full approval by the U.S. Food and Drug Administration on November 13, 2025, for the treatment of adults with relapsed or refractory AML with a susceptible NPM1<\/em> mutation who have no satisfactory alternative treatment options. The approval was supported by data from the KOMET-001 clinical trial, including a 21.4% CR\/CRh rate and median duration of CR\/CRh response of 5 months.1<\/sup>,2<\/sup> KOMZIFTI is now commercially available to prescribers in the U.S. and is available for purchase from a limited network of specialty pharmacies and distributors.<\/p>\n

\u201cThe addition of KOMZIFTI to the NCCN Guidelines\u00ae in Oncology underscores the potential impact of KOMZIFTI for patients with R\/R NPM1<\/em>-mutated AML and supports our commitment to ensuring that patients have access to this important treatment option,\u201d said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. \u201cNPM1<\/em>-mutated disease carries a substantial risk of relapse and historically poor outcomes in the relapsed or refractory setting. We are pleased to have received inclusion in the NCCN guidelines so rapidly after FDA approval and are committed to making KOMZIFTI available to patients in the United States.\u201d<\/p>\n

\n About KOMZIFTI\u2122<\/strong>
\n
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1<\/em> mutation who have no satisfactory alternative treatment options.<\/p>\n

KOMZIFTI is in development for the front-line treatment of AML harboring NPM1 <\/em>mutations, KMT2A<\/em> translocations and FLT3<\/em> mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients earlier in their disease course.<\/p>\n

\n IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION<\/strong>\n <\/p>\n

\n Boxed WARNING: DIFFERENTIATION SYNDROME<\/strong>\n <\/p>\n

\n Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.<\/strong>\n <\/p>\n

\n WARNINGS AND PRECAUTIONS<\/strong>\n <\/p>\n

\n Differentiation Syndrome <\/strong>\n <\/p>\n

KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.<\/p>\n

In the clinical trial, DS occurred in 29 (26%) of 112 patients with R\/R AML with an NPM1<\/em> mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A<\/em>-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A<\/em>-rearranged AML.<\/p>\n

In the 112 patients with an NPM1<\/em> mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.<\/p>\n

Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10\u2079\/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.<\/p>\n

\n QTc Interval Prolongation <\/strong>\n <\/p>\n

KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R\/R AML with an NPM1<\/em> mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia\u2019s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older.<\/p>\n

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.<\/p>\n

\n Embryo-Fetal Toxicity<\/strong>\n <\/p>\n

Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.<\/p>\n

\n ADVERSE REACTIONS<\/strong>\n <\/p>\n

Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in \u2265 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).<\/p>\n

Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in \u2265 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in \u2265 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%).<\/p>\n

\n Most common (\u2265 20%) adverse reactions, including laboratory abnormalities<\/strong>, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%).<\/p>\n

\n DRUG INTERACTIONS<\/strong>\n <\/p>\n

Drug interactions may occur when KOMZIFTI is concomitantly used with:<\/p>\n