FDA grants breakthrough Therapy to ABT 199 (venetoclax) in chronic lymphocytic leukemia- AbbVie and Genentech
The FDA has accepted the New Drug Application (NDA) and granted Priority Review for ABT 199 (venetoclax), from AbbVie and Genentech, for the treatment of people with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion.
The drug was granted Breakthrough Therapy Designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion. The NDA for venetoclax is based in part on data from the pivotal Phase II M13-982 study. A Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA).
Comment: Two other therapies have shown high levels of activity in CLL patients with 17p deletions – AbbVie's Bruton's tyrosine kinase inhibitor Imbruvica (ibrutinib) and the Gilead Sciences PI3K delta inhibitor Zydelig (idelalisib). Patients with 17p deletions generally respond poorly to chemotherapy with or without rituximab (Rituxan). The rapidity of response and the depth of response in CLL patients in the Phase II trial seem greater so far with venetoclax.