FDA greenlights Roche and AbbVie's Venclexta for chronic lymphocytic leukaemia

Venclexta (venetoclax), the oral B-cell lymphoma-2 (BCL-2) inhibitor co-developed by AbbVie and Roche, has been approved by the FDA in combination with Gazyva (obinutuzumab) for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have not received prior treatment.

The US agency reached the decision in just two months through the Breakthrough Therapy pathway, based on the data which indicated that the combo “demonstrated superior progression-free-survival (PFS)”, as assessed by an independent review committee. Specifically, the therapy improved PFS by 67% compared to a standard-of-care combination chlorambucil plus obinutuzumab.

"This FDA approval provides a new chemotherapy-free combination treatment option for patients, and underscores the growing utility of Venclexta in CLL," said Dr Michael Severino, Vice Chairman and President at 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."

Median PFS was not reached throughout the study, but the drug’s safety profile was found to be consistent with previous studies.

"Patients never treated for their CLL have had to rely largely on chemotherapy as their initial treatment," added 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. "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 (MRD) 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."

AbbVie said that full data from the study would be presented at an upcoming medical meeting.

Matt Fellows