AbbVie and Roche’s investigational BCL-2 inhibitor venetoclax could be on the market within the next few months after US and EU regulators kicked off reviews of the new drug.
The two partners confirmed that the US FDA has granted a priority review to venetoclax as a second-line treatment for adults with chronic lymphocytic leukaemia (CLL) associated with a 17p deletion, setting up possible approval of the first-in-class drug within six months.
Meanwhile, in Europe the EMA has started a standard review for the drug as a treatment for patients with CLL associated with either a 17p deletion of TP53 mutation.
CLL is a slow-progressing cancer of the bone marrow and blood and is the most common leukaemia diagnosed in adults in western countries.
The marketing applications for the drug are based largely on the results of the phase II M13-982 study, which involved 157 patients with relapsed, refractory or previously untreated CLL with 17p deletion.
Data presented in December showed a clinically meaningful reduction in the number of cancer cells (an overall response rate or ORR) in 79% of patients, with no unexpected safety signals recorded.
All told, 7.5% of subjects on venetoclax treatment achieved a complete response, and in a few individuals intensive tests revealed no malignant cells in either the blood or bone marrow.
Last May, the FDA awarded breakthrough therapy status to venetoclax for the treatment of CLL in patients with the p17 deletion, which is present in between 3% and 10% of all CLL patients but is disproportionately found in relapsed and refractory cases.
If approved, venetoclax will compete in the market with other new therapies for CLL, including Johnson & Johnson’s first-in-class BTK inhibitor Imbruvica (ibrutinib) and Gilead Sciences’ Zydelig (idelalisib), which were both given a green light in 2014.
Venetoclax is also mid-stage trials for several other cancer types, including non-Hodgkin’s lymphoma (NHL), acute myeloid leukaemia and multiple myeloma, and is due to start combination trials with Imbruvica and Roche’s Gazyva (obinutuzumab) which was approved for first-line CLL therapy alongside chemotherapy in 2013.