AbbVie raises hopes for blood cancer patients

AbbVie has filed its Venclexta (venetoclax) for a new use that it hopes could change the treatment of one of the most aggressive cancers – acute myeloid leukaemia (AML).

Developed in partnership with Roche, Venclexta is already approved in the US for chronic lymphocytic leukaemia, either as second-line monotherapy in patients with a certain mutation, or in a broad second-line use in combination with Roche's Rituxan (rituximab)

AML is one of the most aggressive cancers with a very low survival rate. It affects mainly older patients and is the most common form of acute leukaemia in adults.

AML affects primarily older patients, but only around a third of this group is able to tolerate the intensive chemotherapy required to achieve optimal results.

AbbVie is asking for approval in these patients in combination with a hypomethylating agent (HMA) or with low-dose cytarabine (LDAC) for newly diagnosed patients.

The filing is based on investigational data from two studies: M14-358, a phase 1b trial evaluating venetoclax in combination with an HMA (azacitidine or decitabine), and M14-387, a phase 1/2 trial of venetoclax in combination with LDAC.

Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, 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."

Daniel Pollyea, director of Leukemia Services at University of Colorado Hospital commented on this news: "We have an incredible opportunity to develop better treatment options for people with AML. Still, right now every aspect of this disease represents an unmet need."

In addition to CLL and AML, the drug is also a subject of studies in a range of haematologic malignancies including multiple myeloma (MM), non-Hodgkin lymphoma (NHL) and myelodysplastic syndrome (MDS).