NORTH CHICAGO, Ill., Nov. 1, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that th
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AbbVie Inc. (NYSE: ABBV) has received European Commission (EC) approval of VENCLYXTO (venetoclax) Plus Rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or R/R CLL who have received at least one prior therapy. The EC approval is based on results from the MURANO Phase 3 randomized clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared to bendamustine in combination with rituximab, an established standard of care chemoimmunotherapy regimen for patients with R/R CLL. VENCLYXTO is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech.
The approval will allow more patients to receive VENCLYXTO in the second-line setting and gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for VENCLYXTO as monotherapy in the European Union. VENCLYXTO will now be approved in all 28 member states of the EU, as well as Iceland, Liechtenstein and Norway.