AstraZeneca (AZ) has announced that its Calquence (acalabrutinib) regimens have been recommended by the European Medicines Agency’s human medicines committee to treat chronic lymphocytic leukaemia (CLL).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, be approved for use in adults with previously untreated CLL.
The CHMP’s positive opinion was based on results from the phase 3 AMPLIFY trial, in which Calquence plus venetoclax and Calquence plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 35% and 58%, respectively, compared to standard-of-care chemoimmunotherapy.
After three years, 77% of patients receiving Calquence plus venetoclax and 83% of those being treated with Calquence plus venetoclax and obinutuzumab were progression free, compared to 67% in the chemoimmunotherapy cohort.
Additionally, median progression-free survival was not reached for either Calquence arm and was 47.6 months for chemoimmunotherapy.
An estimated 27,000 cases of CLL were diagnosed in the UK, France, Germany, Spain and Italy in 2024, making the disease the most common type of leukaemia in adults.
Despite being considered an incurable cancer, patients often live with CLL for many years and may remain on continuous treatment, which can have long-term effects.
AZ’s Calquence is designed to inhibit the activity of the Bruton’s tyrosine kinase (BTK) protein that leads to the growth of abnormal cancerous B cells.
The drug is already approved in Europe to treat certain cases of CLL as a continuous duration monotherapy, and it is hoped that the fixed-duration regimens will minimise the risk of adverse events and drug resistance by allowing patients to take breaks from treatment.
Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said: “With this recommendation, Calquence plus venetoclax can potentially be the only all-oral second-generation BTK inhibitor option approved in Europe for patients with previously untreated CLL.
“Calquence has demonstrated efficacy and safety in fixed-duration and treat-to-progression regimens providing patients and their doctors more treatment flexibility.”
The European Commission will now review the CHMP’s recommendation as it makes a decision on Calquence in this indication.