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AstraZeneca Announce Calquence Receives Positive CHMP Opinion for CLL

AstraZeneca's (NYSE: AZN) 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  

Benzinga · -
AstraZeneca's (NYSE: AZN) 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   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.   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   Across both trials, the safety and tolerability of Calquence were consistent with its known profile.2,3   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."   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 prior therapy.   Calquence is approved in the US and in several other countries around the world for the treatment of adult patients with CLL and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is not approved for MCL in Europe.