FDA approval summary: decitabine and cedazuridine tablets for myelodysplastic syndromes

N Kim, KJ Norsworthy, S Subramaniam, H Chen… - Clinical Cancer …, 2022 - AACR
Abstract On July 7, 2020, the Food and Drug Administration approved Inqovi (Otsuka
Pharmaceutical Co.), an oral fixed-dose combination tablet comprising 35 mg decitabine, a …

DNA methyltransferase inhibitor exposure–response: Challenges and opportunities

AB Kagan, DA Garrison, NM Anders… - Clinical and …, 2023 - Wiley Online Library
Although DNA methyltransferase inhibitors (DNMTis), such as azacitidine and decitabine,
are used extensively in the treatment of myelodysplastic syndromes and acute myeloid …

Evaluating complete remission with partial hematologic recovery (CRh) as a response criterion in myelodysplastic syndromes (MDS)

AM Brunner, A Gavralidis, NA Ali, A Hunter… - Blood Cancer …, 2022 - nature.com
Myelodysplastic syndromes (MDS) treated with DNMTI therapy have responses according to
the 2006 IWG response criteria. CR responses have had the strongest association with OS …

Moving toward a conceptualization of measurable residual disease in myelodysplastic syndromes

E Schulz, PD Aplan, SD Freeman… - Blood Advances, 2023 - ashpublications.org
Approximately 90% of patients with myelodysplastic syndromes (MDSs) have somatic
mutations that are known or suspected to be oncogenic in the malignant cells. The genetic …

Cox proportional hazards deep neural network identifies peripheral blood complete remission to be at least equivalent to morphologic complete remission in …

L Pleyer, M Vaisband, M Drost… - American Journal of …, 2023 - Wiley Online Library
The current gold standard of response assessment in patients with myelodysplastic
syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia …

Advances in myelodysplastic syndromes: promising novel agents and combination strategies

YF Madanat, Z Xie, AM Zeidan - Expert Review of Hematology, 2023 - Taylor & Francis
Introduction Myelodysplastic syndromes (MDS) are heterogeneous group of clonal
hematopoietic stem cell neoplasms that have limited approved treatment options. Multiple …

Evolution of Therapeutic Benefit Measurement Criteria in Myelodysplastic Syndromes/Neoplasms

JM Stempel, Z Xie, JP Bewersdorf, M Stahl… - The Cancer …, 2023 - journals.lww.com
Myelodysplastic syndromes/neoplasms (MDS) are heterogeneous, clonal myeloid
neoplasms characterized by ineffective hematopoiesis, progressive cytopenias, and an …

Treatment of Anemia in Lower-Risk Myelodysplastic Syndrome

MR Battaglia, J Cannova, R Madero-Marroquin… - … Treatment Options in …, 2024 - Springer
Current Treatment Options in Oncology not a clear standard of care. For those without
previous luspatercept exposure it can be considered particularly if there is an SF3B1 …

An early glimpse at azacitidine plus venetoclax for myelodysplastic syndromes

L Pleyer, MA Sekeres - The Lancet Haematology, 2022 - thelancet.com
Myelodysplastic syndromes, chronic myelomonocytic leukaemia, and acute myeloid
leukaemia comprise a spectrum of heterogenous myeloid diseases characterised by …

Evaluation of complete response to azacitidine according to the revised International Working Group 2023 response criteria for higher risk MDS. Does it make a …

A Bouchla, SG Papageorgiou, A Symeonidis… - Leukemia, 2023 - nature.com
Higher-risk myelodysplastic syndromes (HR-MDS) are characterized by an increased risk of
acute myeloid leukemia (AML) transformation and compromised overall survival (OS)[1, 2] …