Acalabrutinib (Calquence)

Canada’s Drug Agency (CDA-AMC) recommends that Calquence in combination with venetoclax be reimbursed by public drug plans for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Calquence in combination with venetoclax demonstrates acceptable clinical value compared with chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab [FCR] or bendamustine-rituximab [BR]) in patients with previously untreated CLL. Given that acalabrutinib-venetoclax is expected to be an alternative to chemoimmunotherapy, acceptable clinical value refers to added value versus chemoimmunotherapy. Evidence from a clinical trial (the AMPLIFY trial) showed that in adult patients with previously untreated CLL, treatment with Calquence in combination with venetoclax delayed disease progression or death compared with chemoimmunotherapy (FCR or BR). The results for the other secondary outcomes ― including overall response rate, duration of response, and event-free survival ― further supported the findings. However, there was not enough certainty that the treatment could prolong overall survival (OS). Calquence in combination with venetoclax should only be covered for the treatment of adults with previously untreated active CLL who need treatment and with good performance status. Calquence in combination with venetoclax should not be covered for patients with Richter syndrome, cancer spreading to the central nervous system, uncontrolled autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura.