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AstraZeneca PLC (LSE/STO/Nasdaq:LON:AZN) announced the European Union’s approval of its fixed-duration Calquence (acalabrutinib) regimens for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). This approval follows a positive opinion from the Committee for Medicinal Products for Human Use, based on results from the AMPLIFY Phase III trial.
The AMPLIFY trial demonstrated significant improvements in progression-free survival for patients treated with Calquence in combination with venetoclax, with or without obinutuzumab. Results showed that 77% of patients treated with Calquence plus venetoclax and 83% of those treated with Calquence plus venetoclax and obinutuzumab remained progression-free at three years. This compares to 67% of patients receiving standard chemoimmunotherapy.
The trial also indicated a 35% reduction in the risk of disease progression or death for the Calquence and venetoclax combination, and a 58% reduction for the combination with obinutuzumab, compared to standard treatments. The median progression-free survival was not reached for the Calquence arms, while it was 47.6 months for chemoimmunotherapy.
Barbara Eichhorst, MD, an investigator in the trial, highlighted the appeal of a fixed-duration regimen for minimizing long-term side effects and improving treatment adherence. Dave Fredrickson, Executive Vice President of AstraZeneca (NASDAQ:AZN)’s Oncology Haematology Business Unit, noted that this approval provides a new treatment option for CLL patients in Europe.
The safety profile of Calquence was consistent with previous findings, with no new safety signals observed. Regulatory applications for these regimens are under review in several other countries.
This information is based on a press release statement from AstraZeneca.
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