The U.S. Food and Drug Administration has granted breakthrough therapy designation for its leukemia drug, to speed up the regulatory review process.
On Thursday, AbbVie made the announcement about its venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche for the treatment of chronic lymphocytic leukemia (CLL) for patients with the 17p deletion genetic mutation. Approximately, 3 to 10 percent of all first-line patients have this mutation, while up to half of treatment-resistant patients are in that group.
CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell. About one quarter of new leukemia cases diagnosed in the U.S. are CLL, according to the American Cancer Society. The median life expectancy for those with CLL with 17p deletion is less than two to three years.
Venetoclax works by inhibiting the BCL-2 protein, which prevents cell death.
Read the entire release here.