CHMP recommends approval Calquence for chronic lymphocytic leukaemia,- AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence (acalabrutinib), from AstraZeneca, intended for the treatment of chronic lymphocytic leukaemia (CLL).
Calquence will be available as 100 mg hard capsules. Acalabrutinib, a protein kinase inhibitor, acts by inhibiting the Bruton tyrosine kinase (BTK), thus preventing signalling for B-cell survival and proliferation and resulting in blocking cellular adhesion, trafficking, and chemotaxis. The benefits with Calquence are its ability to prolong progression-free survival when used on its own or in combination with obinutuzumab. The most common side effects are respiratory tract infections, headache bruising, contusion, diarrhoea, nausea, rash, musculoskeletal pain, fatigue, decreased haemoglobin and decreased platelets.