Onureg

Oncology· 142 cited findings· 1 source document

What the regulatory reviews say

Onureg is recommended for marketing authorization as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not candidates for, or choose not to proceed to, hematopoietic stem cell transplantation (HSCT). The proposed starting dose is 300 mg orally, once daily. The Marketing Authorisation application was submitted on 30 April 2020, and a CHMP positive opinion was issued on 22 April 2021.

Key efficacy findings include a median OS improvement of 9.9 months. The median relapse-free survival was 5.4 months. For HDC/IL-2 versus control in AML, the LFS had a Hazard Ratio (HR) of 0.71 with a p-value of 0.01. In the first CR subgroup, the LFS HR was 0.69 (p-value 0.01). For midostaurin versus placebo in FLT3 mutant AML, the median OS had an HR of 0.78 (p-value 0.009), and the EFS p-value was 0.002.

Regarding safety, gastrointestinal toxicities were observed in 92% of patients. The oral LD50 of azacitidine in Swiss mice was 572 mg/kg, while the intraperitoneal LD50 was 116 mg/kg, and the intravenous LD50 was 117 mg/kg.

Key figures — cited to the source page

median OS improvement	9.9 months	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.98
median relapse-free survival	5.4 months	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.98
LFS for HDC/IL-2 vs control in AML	HR = 0.71	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.11
p-value for LFS for HDC/IL-2 vs control in AML	0.01	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.11
gastrointestinal toxicities incidence	92 %	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.98
Proposed starting dose	300 mg orally, once daily	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.12
marketing authorisation recommendation	recommended	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.99
CHMP positive opinion date	22 April 2021	Bristol-Myers Squibb Company — Onureg EMA EPAR public assess, p.7

Source documents

Bristol-Myers Squibb Company — Onureg EMA EPAR public assessment report (EMEA/H/C/004761, 2021) (2021)

Explore the full evidence

All 142 cited findings for Onureg — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.