AstraZeneca PLC — Calquence EMA EPAR public assessment report (EMEA/H/C/005299, 2020)

AstraZeneca PLC · 2020 · EMA EPAR public assessment report · company profile →

Report summary

This report summarizes the EMA's 2020 assessment of Calquence (acalabrutinib) for chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). Non-clinical studies demonstrated acalabrutinib's potent and selective BTK inhibition, with favorable pharmacokinetics and toxicology. Clinical trials (ACE-CL-007, ACE-CL-309, ACE-CL-001) showed significant improvements in progression-free survival for acalabrutinib, both as monotherapy and in combination, in previously untreated and relapsed/refractory CLL patients. While adverse events like neutropenia and infections were observed, the overall benefit-risk balance was deemed positive, leading to a recommendation for marketing authorization, despite the withdrawal of its orphan designation.

Key findings — cited to the page

SAEs Grade ≥3 in Acala-mono arm	29.6 %	ACE-CL-007 · p.141
TEAEs Grade ≥3 in Acala arm	49.4 %	ACE-CL-309 · p.141
TEAEs Grade ≥3 in Obin+Clb arm	69.8 %	ACE-CL-007 · p.141
SAEs Grade ≥3 in Acala+Obin arm	38.8 %	ACE-CL-007 · p.141
Infusion related reactions (Obin) Grade ≥3 in Acala+Obin arm	2.2 %	ACE-CL-007 · p.141
Infusion related reactions (Obin) Grade ≥3 in Obin+Clb arm	5.3 %	ACE-CL-007 · p.141
TEAEs Grade ≥3 in Acala+Obin arm	70.2 %	ACE-CL-007 · p.141
TEAEs Grade ≥3 in Acala-mono arm	49.7 %	ACE-CL-007 · p.141
most commonly reported AE Grade ≥3 neutropenia in Obin+Clb arm	41.1 %	ACE-CL-007 · p.141
most commonly reported AE Grade ≥3 thrombocytopenia in Obin+Clb arm	11.8 %	ACE-CL-007 · p.141
SAEs Grade ≥3 in Obin+Clb arm	19.5 %	ACE-CL-007 · p.141
TEAE Grade ≥3 in IR group	89.8 %	ACE-CL-309 · p.141

Source: AstraZeneca PLC ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →