Bristol Myers Squibb announced that the European Commission (EC) has granted full marketing authorisation for azacitidine tablets as a maintenance therapy in adult patients with acute myeloid leukaemia (AML) who 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, including those who choose not to proceed to, haematopoietic stem cell transplantation (HSCT).
Azacitidine is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes.
The centralised marketing authorisation approves use of azacitidine tablets in all EU member states, as well as Norway, Iceland and Liechtenstein.*
Azacitidine is approved in the United States for the continued treatment of adult patients with AML who achieved first CR or CRi following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
In Canada, azacitidine is approved as a maintenance therapy for adult patients with AML who achieved CR or CRi following induction therapy with or without consolidation treatment, and who are not eligible for HSCT.
“An unmet need exists for maintenance therapy options for acute myeloid leukaemia in the European Union, given responses to induction therapy may be of short duration and the risk of relapse is high, especially for patients not eligible for stem cell transplant,” said Andrew Wei, MBBS, Ph.D., QUAZAR® AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia.
“The approval of azacitidine tablets by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukaemia, across a range of subtypes.”
The EC approval of azacitidine tablets was based on results from the QUAZAR® AML-001 study, a Phase 3, international, randomised, double-blind trial.
Eligible patients were ages 55 years or older, had newly diagnosed AML, intermediate or poor cytogenetics, had achieved first CR or CRi following intensive induction chemotherapy with or without consolidation treatment (per investigator preference prior to study entry), and were not candidates for HSCT at the time of screening.
“Today’s approval of azacitidine tablets represents a significant advance for patients in the European Union living with acute myeloid leukaemia, who have remained in urgent need of maintenance therapies for this aggressive blood cancer,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb.
“We are committed to helping to improve long-term outcomes and greatly extending survival for patients with hard-to-treat diseases, as we work collaboratively with European Union member states to make azacitidine tablets available to eligible patients as quickly as possible.”
*Centralised Marketing Authorisation does not include approval in Great Britain (England, Scotland and Wales).
Source: Bristol Myers Squibb