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AbbVie: VENCLYXTO Plus Rituximab Gets Europe Approval To Treat CLL Patients

AbbVie Inc. (ABBV), a research-based global biopharmaceutical company, announced Thursday that it has received European Commission 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.

This approval allows 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. The approval is valid in all 28 member states of the EU, as well as Iceland, Liechtenstein and Norway.

VENCLYXTO is being developed by AbbVie and Roche (RHHBY). It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

The company noted that 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.

CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes are found predominantly in the blood and bone marrow.

In September 2018, AbbVie announced the European Committee for Medicinal Products for Human Use or CHMP granted a positive opinion for the Marketing Authorization Application for VENCLYXTO plus rituximab for the treatment of patients with R/R CLL.

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