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AML | Clinical
FDA Halts Studies of Magrolimab Plus Azacitidine Amid Safety Discrepancy
January 26, 2022
With a partial clinical hold placed by the FDA, all studies of magrolimab plus azacitidine must halt screening and enrollment.
FDA Lifts Partial Clinical Hold from KOMET-001 in R/R AML
January 24, 2022
The KOMET-001 study may resume after the FDA lifted the partial clinical hold for safety.
Promising New Regimens for Treating Acute Myeloid Leukemia
January 12, 2022
Alice S. Mims, MD, MSCR, discusses new regimens for treating patients with acute myeloid leukemia, including anti-CD47 immunotherapy, IDH inhibitors, and menin inhibitors.
Aspacytarabine Shows Promise in Newly-Diagnosed Acute Myeloid Leukemia
January 10, 2022
Aspacytarabine for acute myeloid leukemia showed a complete response rate of 37% in phase 2 study.
FDA Grants Breakthrough Therapy Designation to Device to Treat AML-Induced Depression
January 10, 2022
BNT200 was granted an FDA breakthrough device designation for the treatment of AML-induced depression and anxiety present during the high-intensity induction chemotherapy phase.
Novel IRAK4 Inhibitor Demonstrates Clinical Efficacy, Acceptable Safety in AML and MDS
January 08, 2022
CA-4948 was found to have a complete remission rate of 40% and an objective response rate of 57% in some patients with acute myeloid leukemia and myelodysplastic syndrome.
APVO436 Treatment Does Not Appear to Be Adversely Impacted by CRS or Interventional Steroids in AML/MDS
January 02, 2022
Although cytokine release syndrome can occur in patients treated with APVO436, the event can be managed with steroids without adversely affecting treatment.
FDA Grants Fast Track Designation to CYNK-001 for AML Treatment
December 29, 2021
A novel natural killer cell therapy is now on the fast track to FDA approval and being assessed in a phase 1 clinical trial.
KO-539 Shows Preclinical Activity Against KMT2A-Rearranged and NPM1-Mutant AML
December 17, 2021
Early research shows that the menin inhibitor, KO-539, may have synergy with other targeted agents for the treatment of KMT2A-rearranged and NPM1-mutated acute myeloid leukemia tumors.
First Patient Dosed in Trial of Entospletinib for NPM1-Mutated AML
December 17, 2021
Entospletinib in combination with chemotherapy will be evaluated in the phase 3 AGILITY study in patients with NPM1-mutated AML.