AbbVie Gets Euro Panel Nod for Chronic Lymphocytic Leukemia Combo

– If approved by the European Commission (EC), VENCLYXTO® plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
– The positive opinion is based on the MURANO Phase 3 clinical trial, in which VENCLYXTO plus rituximab met the primary endpoint of prolonged progression-free survival and the majority of patients achieved undetectable minimal residual disease in the peripheral blood, compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.[1]
– The safety profile of the combination of VENCLYXTO plus rituximab is consistent with the known safety profile of each medicine alone.[1]   

AbbVie (NYSE: ABBV), 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 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.

“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.”

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 death²) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.

https://www.biospace.com/article/abbvie-receives-positive-chmp-opinion-for-a-novel-chemotherapy-free-combination-of-venclyxto-venetoclax-tablets-with-rituximab-as-a-treatment-with-a-fixed-duration-for-patients-with-chronic-lymphocytic-leukemia/