AbbVie, a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO® (venetoclax tablets) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy.
The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
In 2016, VENCLYXTO was approved by the EC as a monotherapy for the treatment of R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
And also for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
If approved by the EC, VENCLYXTO plus rituximab could be prescribed to a broader patient population with R/R CLL than the currently approved indication for VENCLYXTO monotherapy in the EU.
Relapsed/refractory chronic lymphocytic leukemia
"This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
"The combination of VENCLYXTO with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course," said Severino.
The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared with bendamustine in combination with rituximab.
At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint assessed at the end of combination therapy (nine-month assessment). The majority of patients in the trial who received VENCLYXTO plus rituximab achieved uMRD in the peripheral blood.
"The venetoclax plus rituximab combination has the potential to be truly transformative for patients with relapsed/refractory CLL," said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of Cancer Medicine at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia.
"The progression-free survival observed in the MURANO trial, and the fixed duration of treatment that may allow patients to stop treatment, are encouraging developments with the potential to advance the care and management of patients with relapsed/refractory CLL."