AstraZeneca’s Calquence Regimen Gains EU Approval Recommendation for CLL

 

• AstraZeneca’s Calquence regimen for CLL recommended for EU approval.
• Calquence shows significant survival improvement in Phase III trial.
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AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for a fixed-duration regimen of its drug Calquence, in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in the EU. This recommendation is based on the AMPLIFY Phase III trial results, which demonstrated significant improvements in progression-free survival compared to standard chemoimmunotherapy. The approval could position Calquence as a leading treatment option in Europe, offering patients a more flexible and potentially safer treatment regimen.

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