AbbVie gets FDA nod for Venclexta combination treatment
AbbVie has received the Food and Drug Administration’s green light for Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL.
CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called B lymphocytes become cancerous and multiply abnormally.
"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of Venclexta," Michael Severino, vice chairman and president, AbbVie said.
"Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment," said Michael Hallek, lead investigator of the CLL14 study, department of internal medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany, and head of the German CLL Study Group.
Hallek added, "The approval of the Venclexta combination means that patients with previously untreated CLL now have a finite duration, chemotherapy-free treatment option that can allow them to live longer without disease progression, induce high rates of minimal residual disease negativity and, importantly, allow them to complete their course of therapy within 12 months. This is a major step forward in how previously untreated CLL is managed and further supports the growing benefits offered by Venclexta in CLL."
Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the United States.
CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called B lymphocytes become cancerous and multiply abnormally.
"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of Venclexta," Michael Severino, vice chairman and president, AbbVie said.
"Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment," said Michael Hallek, lead investigator of the CLL14 study, department of internal medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany, and head of the German CLL Study Group.
Hallek added, "The approval of the Venclexta combination means that patients with previously untreated CLL now have a finite duration, chemotherapy-free treatment option that can allow them to live longer without disease progression, induce high rates of minimal residual disease negativity and, importantly, allow them to complete their course of therapy within 12 months. This is a major step forward in how previously untreated CLL is managed and further supports the growing benefits offered by Venclexta in CLL."
Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the United States.