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CALQUENCE (AstraZeneca Pty Ltd)

Product name
CALQUENCE
Sponsor
AstraZeneca Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
249 (255 working days)
Active ingredients
acalabrutinib maleate monohydrate
Registration type
EOI
Indication

Chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL)

CALQUENCE as monotherapy is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

CALQUENCE as monotherapy or in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). For details of the combination regimens, see Section 5.1 Pharmacodynamic properties / Clinical trials.

CALQUENCE in combination with venetoclax with or without obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). For details of the combination regimens, see Section 5.1 Pharmacodynamic properties / Clinical trials.