Biopharmaceutical company AbbVie recently received Breakthrough Therapy Designation from the Food and Drug Administration (FDA) for venetoclax, its latest cancer-fighting drug.
The designation was given for the drug as a combination treatment for individuals with untreated acute myeloid leukemia (AML) who aren't eligible for high-dose chemotherapy. Under the designation, the B-cell lymphoma-2 inhibitor is to be used with hypomethylating agents.
The FDA granted the first Breakthrough Therapy Designation for venetoclax in April 2015 to be used on previously treated individuals with chronic lymphocytic leukemia (CLL) with the 17p deletion generic mutation. The second breakthrough therapy status for the drug was given just last month as a combination treatment for individuals with relapsed/refractory CLL. For that designation, venetoclax is to be used with the drug rituximab.
The Breakthrough Therapy Designation was created to advance the development and provide prompt access to treatments for serious health conditions.
"Acute myeloid leukemia is an aggressive and life-threatening cancer," Dr. Michael Severino, chief scientific officer of AbbVie, said. "Unfortunately, for many AML patients, intensive therapy is not an option, causing a high need for new, effective and alternative treatments. This third Breakthrough Therapy Designation for venetoclax highlights our efforts to pursue the significant and broad potential of this therapy."
AbbVie is developing venetoclax in collaboration with Genentech and Roche.