The U.S. Food and Drug Administration (FDA) has approved AbbVie’s 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 (RTOR) pilot program, which led to approval in just over two months, following submission of the complete application.
The CLL14 trial demonstrated superior progression-free survival as assessed by an independent review committee (PFS; the time from initiation of treatment until disease progression or death) in patients treated with VENCLEXTA plus obinutuzumab compared to patients who received chlorambucil plus obinutuzumab, a commonly used standard of care.
With a median follow-up of 28 months (range: 0.1 to 36 months), VENCLEXTA plus obinutuzumab reduced the risk of progression or death by 67% compared with chlorambucil plus obinutuzumab.
VENCLEXTA, an oral B-cell lymphoma-2 (BCL-2) inhibitor, has been granted five Breakthrough Therapy designations from the FDA.
Venetoclax is being developed by AbbVie and Roche and is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
Dr Michael Severino, Vice Chairman and President, AbbVie, said: “This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of VENCLEXTA in CLL.”
Dr 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, said: “This is a major step forward in how previously untreated CLL is managed and further supports the growing benefits offered by VENCLEXTA in CLL.”
Data from the CLL14 trial is expected to be presented at an upcoming medical meeting and published in a journal this year.