US EditionTwo Drugs Approved for NPM1-Mutated Leukemia
Ziftomenib offers a new oral treatment option with a 21.4% complete remission rate in adults with relapsed/refractory NPM1-mutated AML lacking alternatives, FDA said.
- On Thursday, the U.S. Food and Drug Administration approved ziftomenib for adults with relapsed or refractory NPM1‑mutated AML, joining revumenib cleared late last month.
- NPM1 mutations, present in roughly 30% of acute myeloid leukemia cases, create an actionable target as many patients with relapsed/refractory NPM1‑mutated AML relapse early, with 70% relapsing within three years.
- KOMET‑001 showed a CR+CRh rate of 21.4% with median duration 5.0 months and median time to response 2.7 months in 112 adults treated with ziftomenib .
- Kura Oncology said it is fully prepared to launch KOMZIFTI today and deliver the medicine to patients in need, equipping physicians with a new once-daily oral therapy for this vulnerable population.
- With safety concerns prominent, KOMZIFTI includes a Boxed Warning for differentiation syndrome, reported in 26%, and requires ECG monitoring and interruption if QTc exceeds 500 ms or changes by over 60 ms.
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MedPage Today
Anti-Aging, Acupuncture and Health NewsTwo Drugs Approved for NPM1-Mutated Leukemia
(MedPage Today) -- The FDA has approved two targeted menin inhibitors for the treatment of relapsed/refractory NPM1-mutated acute myeloid leukemia (AML). Ziftomenib (Komzifti) was approved on Thursday for adults with relapsed/refractory NPM1-mutated...
FDA approves ziftomenib for adults with relapsed, refractory AML
The FDA approved ziftomenib for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation. This indication for ziftomenib (Komzifti, Kura Oncology), an oral menin inhibitor, applies to adults who do not have satisfactory alternative treatment options.
Globe Newswire
dailyguardian.caKura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by...
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