AstraZeneca’s Calquence approved by EC for first-line chronic lymphocytic leukaemia use
An estimated 27,000 cases of the disease were diagnosed in the UK, France, Germany, Spain and Italy in 2024
AstraZeneca (AZ) has announced that its fixed-duration Calquence (acalabrutinib)-based regimens have been approved by the European Commission (EC) to treat chronic lymphocytic leukaemia (CLL) in the first-line setting. The oral Bruton’s tyrosine kinase (BTK) inhibitor has been specifically authorised for use alongside venetoclax, with or without obinutuzumab, in adults with previously untreated CLL.
CLL is the most common form of leukaemia in adults, with an estimated 27,000 cases diagnosed in the UK, France, Germany, Spain and Italy in 2024. Despite being considered an incurable cancer, patients often live with the disease for many years and may remain on continuous treatment.
Calquence is designed to inhibit the activity of a protein that leads to the growth of abnormal cancerous B cells, and is already approved in the EU as a monotherapy for previously treated CLL. The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by data from the phase 3 AMPLIFY trial, which compared the Calquence regimens against standard-of-care (SOC) chemoimmunotherapy.
Results demonstrated that 77% of patients randomised to receive Calquence plus venetoclax and 83% of those treated with Calquence plus venetoclax and obinutuzumab were progression free at three years, compared to 67% in the SOC chemoimmunotherapy cohort.
Calquence in combination with venetoclax and Calquence plus venetoclax and obinutuzumab reduced the risk of disease progression or death by 35% and 58%, respectively, compared to SOC chemoimmunotherapy.
Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “This approval brings a new fixed-duration treatment option to patients with previously untreated CLL across Europe.” Fredrickson added that Calquence plus venetoclax is “the first and only” all-oral combination treatment option with a second-generation BTK inhibitor to be approved in the EU, giving patients and their physicians “more flexibility in managing this incurable blood cancer”.
The approval comes just one month after the EC approved Calquence as part of a combination treatment for patients with mantle cell lymphoma (MCL), a rare and typically aggressive form of non-Hodgkin lymphoma. The drug was authorised for use alongside SOC chemoimmunotherapy, bendamustine and rituximab, in adults with previously untreated MCL who are not eligible for autologous stem cell transplant.
