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Calquence receives positive CHMP opinion for CLL
Calquence receives positive CHMP opinion for CLL.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 1366U\n AstraZeneca PLC\n 27 July 2020\n \n \n \n 27 July 2020 07:10 BST\n \n \n \n Calquence\n \n \n recommended for approval in the\nEU by CHMP for chronic lymphocytic leukaemia\n \n \n \n Recommendation based on two Phase III trials demonstrating superior progression-free survival across multiple settings while maintaining favourable tolerability\n \n AstraZeneca's Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.1\n \n The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from two Phase III clinical trials, ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL.\n \n \n \n In the ELEVATE TN trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared to standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.2 In the ASCEND trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive and free from disease progression after 12 months compared to 68% of patients on rituximab combined with idelalisib or bendamustine.3\n \n \n \n \n Across both trials, the safety and tolerability of Calquence were consistent with its known profile.2,3\n \n \n José Baselga, Executive Vice President, Oncology R&D said: \"With its outstanding efficacy and tolerability profile, Calquence can offer important advantages to patients with chronic lymphocytic leukaemia who are typically older, facing multiple comorbidities and often require treatment for many years. This positive recommendation brings us closer to providing a much-needed new treatment option to patients in Europe who are suffering from this chronic blood cancer.\"\n \n The CHMP recommendation is for Calquence monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL and for Calquence monotherapy for the treatment of adult patients with CLL who have received at least one ...