AbbVie’s Venclexta granted full US approval in AML

The US Food and Drug Administration (FDA) has fully approved AbbVie’s Venclexta in acute myeloid leukaemia (AML).

Venclexta (venetoclax) has been approved in combination with azacytidine or decitabine/low-dose cytarabine (LDAC) for the treatment of newly-diagnosed AML in adults who are aged 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy.

The approval is based on data from the phase III VIALE-A and VIALE-C studies and updated data from the phase Ib M14-358 and the phase I/II M14-387 studies.

In the VIALE-A study, positive overall survival data observed in an interim analysis led to an early submission supporting the FDA approval of Vencelxta in AML.

The trial showed that patients of the active regimen of Venclexta plus azacytidine achieved a 34% reduction in the risk of death compared to azacytidine in combination with placebo.

The median overall survival for patients in the Venclexta arm was 14.7 months versus 9.6 months in the placebo arm.

Additionally, patients in the Venclexta arm achieved a complete remission rate of 37% with a median duration of 18.0 months compare with patients in the placebo arm with a rate of 18% with a median duration of 13.4 months.

"AML is a complex and challenging disease with generally low survival rates. This approval is significant because data from our VIALE-A trial has shown that newly-diagnosed patients, who cannot undergo intensive chemotherapy, lived longer when treated with VENCLEXTA plus azacitidine than those treated with azacitidine alone," said Mohamed Zaki, vice president and global head of oncology development, AbbVie.

"This trial also provides physicians more information for managing patients - from treatment initiation, to assessing response and management post disease remission,” he added.