AstraZeneca’s Calquence approved in EU for treating CLL

A fixed-duration regimen of AstraZeneca’s (AZN) Calquence in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union, EU, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia, CLL. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from the pivotal AMPLIFY Phase III trial, presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. Results from the AMPLIFY trial showed 77% of patients treated with Calquence plus venetoclax and 83% of patients treated with Calquence plus venetoclax and obinutuzumab were progression free at three years, versus 67% of patients treated with standard-of-care chemoimmunotherapy. Median progression-free survival was not reached for either experimental arm versus 47.6 months for chemoimmunotherapy. Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy. Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to chemoimmunotherapy.