Regulators in the US and Europe have agreed to review AbbVie’s venetoclax as a potential treatment for certain adults with chronic lymphocytic leukaemia (CLL).
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) and granted priority review for venetoclax to treat CLL in adults who have received at least one prior therapy, including patients with 17p deletion.
In addition, the European Medicines Agency (EMA) has validated the company’s marketing authorisation application (MAA) for venetoclax to treat CLL patients with 17p deletion or TP53 mutation.
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated to treat several types of cancer.
The drug is designed to selectively inhibit the function of the BCL-2 protein, which prevents programmed cell death of some cells, including lymphocytes, and can be over expressed in some cancer types.
The company has collaborated with Genentech and Roche to develop venetoclax, which is currently being evaluated in phase III clinical trials to treat relapsed / refractory CLL, along with trials in various other cancers.
AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: "The FDA acceptance and EMA validation of AbbVie’s Venetoclax submissions mark a major step forward as we work to become a global leader in oncology, providing new therapies for patients with cancer.
"Patients are always our number one priority and we accelerated our efforts to bring venetoclax, the first BCL-2 inhibitor, to patients with CLL in need of new therapies, including those with 17p deletion who typically have a poor prognosis."
Both NDA and MAA were supported by data from a Phase II data study, which met its primary endpoint of achieving an overall response rate, with no unexpected safety signals.
The company noted that venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.