AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for the use of its venetoclax drug to treat acute myeloid leukaemia (AML), an aggressive blood cancer.
The application seeks approval for venetoclax’s combination with a hypomethylating agent (HMA) or low-dose cytarabine (LDAC) in newly diagnosed patients who are ineligible for intensive chemotherapy.
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor being developed by AbbVie in collaboration with Roche. It already secured approval for the treatment of another blood cancer, chronic lymphocytic leukaemia (CLL).
The sNDA includes results obtained during the investigational M14-358 and M14-387 clinical trials.
M14-358 is a Phase Ib trial designed to assess venetoclax in combination with an HMA (azacitidine or decitabine), while M14-387 is a Phase I/II trial of the drug in conjunction with LDAC.
AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: “AML is an especially lethal and aggressive form of blood cancer with limited advances in care in three decades and few treatment options for patients ineligible for intensive chemotherapy.
“The data submitted to the FDA may potentially reshape how AML is treated. We look forward to working with the FDA and other health authorities during the review of these data.”
Venetoclax secured four FDA breakthrough therapy designations, including combination with an HMA and with LDAC for treatment-naïve AML patients.
The drug also obtained the FDA approval as a monotherapy or in combination with rituximab for relapsed/refractory (R/R) CLL or small lymphocytic lymphoma (SLL) patients who previously received at least one therapy.
It is also being investigated for the treatment of various hematologic cancers such as multiple myeloma (MM), non-Hodgkin lymphoma (NHL) and myelodysplastic syndrome (MDS).