The European Commission (EC) has granted approval for AbbVie to use Venclyxto (venetoclax) in conjunction with rituximab to treat people suffering from chronic lymphocytic leukaemia (CLL).
The indication covers relapsed/refractory CLL (R/R CLL) patients who have undergone at least one prior therapy. Previously, Venclyxto was approved as a monotherapy in the European Union (EU).
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Venclyxto is designed to selectively bind to and block the B-cell lymphoma-2 (BCL-2) protein, which is known to build-up in some cancers and prevent their natural death.
The drug is being developed by AbbVie in collaboration with Roche. It holds regulatory approvals in more than 50 countries.
AbbVie chief scientific officer Michael Severino said: “The approval of Venclyxto in combination with rituximab is an important step forward in providing patients with relapsed/refractory chronic lymphocytic leukaemia a strong chance to live longer without their disease progressing.
“We look forward to bringing Venclyxto to more patients with chronic lymphocytic leukaemia, while continuing to further the research and development of therapies with the potential to transform the standards of care in blood cancers.”
The European Commission reviewed data from the randomised Phase III MURANO clinical trial conducted to compare the efficacy and safety of Venclyxto plus rituximab with bendamustine and rituximab combination in a total of 389 R/R CLL patients.
During primary analysis, the investigational combination led to statistically significant improvement in progression-free survival, demonstrating 83% decrease in the risk of disease progression or death, as well as enhanced overall survival (OS).
Around 62.4% of the participants treated with Venclyxto plus rituximab achieved undetectable minimal residual disease (uMRD) in the peripheral blood at nine months, compared to 13.3% with bendamustine plus rituximab.
The safety profile of the investigational combination was found to be consistent with the existing data of the individual drugs. The most common adverse reactions for the combination were neutropenia, diarrhoea and upper respiratory tract infection.
