publication date: May. 17, 2019

Drugs & Targets

FDA approves Venclexta in chronic lymphocytic leukemia

FDA has approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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.

Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

“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, vice chairman and president of 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.”

Data from the CLL14 trial is expected to be presented at an upcoming medical meeting and published in a journal this year.

“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.

“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 … Continue reading FDA approves Venclexta in chronic lymphocytic leukemia

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