The US Food and Drug Administration (FDA) has granted priority review for venetoclax to treat CLL in adults who have received at least one prior therapy, including patients with 17p deletion.
The European Medicines Agency (EMA) has also validated AbbVie’s marketing authorization application 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 assessed to treat several types of cancer.
AbbVie said the BCL-2 protein avoids programmed cell death of various cells, including lymphocytes, and can be over expressed in certain cancer types.
The company has collaborated with Genentech and Roche to develop venetoclax, which is designed to selectively inhibit the function of the BCL-2 protein.
AbbVie executive vice president of research and development 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."
The filings were supported by data from a phase II data study which AbbVie says met its primary endpoint of achieving an overall response rate, with no unexpected safety signals.
Venetoclax is currently being evaluated in phase 3 clinical studies for the treatment of relapsed/refractory CLL, along with trials in various other cancers.
Image: Peripheral blood smear showing CLL cells. Photo: courtesy of VashiDonsk at the English language Wikipedia.