Posted by Michael Wonder on 15 May 2019
AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients
15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program.
AbbVie today announced that the U.S. FDA has approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted Breakthrough Therapy designation for this combination therapy, and early submission of the data was provided under the real-time oncology review pilot program, which led to approval in just over two months, following submission of the complete application.
"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of Venclexta in CLL," said Michael Severino, M.D., vice chairman and president, AbbVie. "The approval is based on findings from the CLL14 trial in which patients received a 12-month treatment regimen. The majority of patients receiving Venclexta in the trial remained progression-free at two years."
