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AstraZeneca PLC on Friday said fixed-duration Calquence-based regimens have been approved in the EU to treat patients with chronic lymphocytic leukaemia. The Cambridge, England-based pharmaceutical company said acalabrutinib, brand name Calquence, in combination with venetoclax and with or without obinutuzumab, has been approved for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. The company said the approval follows a positive opinion from the Committee for Medicinal Products for Human Use and was based on results from the Amplify phase three trial. The 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. This compared to 67% of patients treated with standard-of-care chemoimmunotherapy. Chronic lymphocytic leukaemia is the most common type of leukaemia in adults. Executive Vice President Dave Fredrickson said: ‘Today’s approval brings a new fixed-duration treatment option to patients with previously untreated chronic lymphocytic leukaemia across Europe. ‘Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation [Bruton tyrosine kinase] inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer.’ Regulatory applications for these regimens are currently under review in several countries based on the Amplify results, AstraZeneca added. Shares in AstraZeneca were up 0.8% at 10,780.00 pence in London on Friday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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