Purpose of resubmission The standard re-entry resubmission requested an Authority Required General Schedule listing of acalabrutinib, for use in combination with obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), who are considered unsuitable for treatment with fludarabine-based chemoimmunotherapy.

№ lp_1_23442

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Acalabrutinib resubmission for approval in the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), proposing combination therapy with obinutuzumab.

Year: 2023

Region / city: Australia

Topic: Oncology, Pharmaceuticals

Document Type: Resubmission

Institution: Australian Government, Pharmaceutical Benefits Advisory Committee

Author: AstraZeneca Pty Ltd.

Target Audience: Healthcare professionals, regulatory bodies

Effective Period: Ongoing

Approval Date: November 2021

Date of Changes: November 2021

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