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AstraZeneca's Calquence Receives Positive CHMP Opinion For Chronic Blood Cancer

British drug major AstraZeneca Plc. (AZN.L,AZN) announced Monday that its Calquence (acalabrutinib) has been recommended for marketing authorisation in the European Union for chronic lymphocytic leukaemia or CLL, the most common type of leukaemia in adults.

Calquence is a next-generation, selective inhibitor of Bruton's tyrosine kinase or BTK.

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency based its positive opinion on results from two Phase III clinical trials. The trials, ELEVATE TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL, demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Across both trials, the safety and tolerability of Calquence were consistent with its known profile.

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 to treat adult patients with CLL and for adult patients with mantle cell lymphoma or MCL who have received at least one prior therapy. Calquence is not approved for MCL in Europe.

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."

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