dm+d

Unassigned

New Medicines

Relapsed or refractory acute myeloid leukaemia (AML) - second-line

Information

New molecular entity
Otsuka
Astex Pharmaceuticals

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Sep 20Development discontinued due to negative PIII results [5].

Category

DNA cytosine 5 methyltransferase 1 inhibitor
AML affects < 1.2 in 10,000 people in the EU (equivalent to not more than 61,000 people)
Relapsed or refractory acute myeloid leukaemia (AML) - second-line
Subcutaneous

Trial or other data

Oct 20Initial results from PIII ASTRAL-2 demonstrate that guadecitabine failed to improve overall survival compared to the control arm (physician´s choice of alternative therapy) [4].

Myelodysplastic syndromes (MDS) or chronic myelomonocytic leukaemia - second-line

Information

Licence extension / variation
Otsuka
Astex Pharmaceuticals

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Sep 20Development discontinued due to negative PIII results [7].

Category

DNA cytosine 5 methyltransferase 1 inhibitor
The incidence of MDS is approximately 4/100,000 population/year. It is predominantly a disease of the elderly with an incidence of over 30/100,000/year in those over the age of 70 years. The overall prevalence of the syndromes appears to be increasing due to an ageing population and better diagnosis [1].
Myelodysplastic syndromes (MDS) or chronic myelomonocytic leukaemia - second-line
Subcutaneous

Trial or other data

Oct 20PIII ASTRAL-3 trial has demonstrated that guadecitabine failed to improve overall survival compared to control (physicians choice of alternative therapy) [6].