FDA Grants Breakthrough Designation to Chemotherapy-Free Combo Therapy for CLL – APhA submits compounding comments to FDA. – (866) 348-2889.
Genentech and AbbVie have announced the submission of the supplemental New Drug Application to the FDA for venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for patients with previously-untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions, according to a press release. The sNDA has been granted Breakthrough Therapy Designation.
This is the fifth Breakthrough Therapy Designation for venetoclax, which is being studied across a range of blood cancers. Venetoclax has also been approved for the treatment of previously-treated adults with CLL or small lymphocytic lymphoma and in combination with azacytidine, decitabine, or low-dose cytarabine for certain adults with newly-diagnosed acute myeloid leukemia.