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LONDON - AstraZeneca PLC (LON:AZN)’s Calquence (acalabrutinib), in combination with venetoclax and optionally obinutuzumab, has been recommended for approval as a first-line treatment for adult patients with chronic lymphocytic leukaemia (CLL) in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) endorsed the regimen based on the AMPLIFY Phase III trial results, which indicated a significant improvement in progression-free survival compared to standard chemoimmunotherapy.
The trial, which enrolled patients from 2019 to 2021, found that the risk of disease progression or death was reduced by 35% with Calquence plus venetoclax, and by 58% when obinutuzumab was added, versus the standard chemoimmunotherapy. After three years, 77% and 83% of patients were progression-free with the Calquence combinations, respectively, compared to 67% with chemoimmunotherapy.
Dr. Wojciech Jurczak, an investigator in the trial, highlighted the benefit of fixed-duration regimens, which can potentially reduce long-term adverse events and the risk of drug resistance by allowing treatment breaks. Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca (NASDAQ:AZN), noted that the recommendation could make Calquence plus venetoclax the only all-oral second-generation BTK inhibitor option approved in Europe for untreated CLL.
CLL, a prevalent adult leukemia, had over 117,000 new cases globally in 2021. The AMPLIFY trial results were presented at the American Society of Haematology (ASH) 2024 Annual Meeting and published in The New England Journal of Medicine. Regulatory applications based on these results are under review in several countries.
The safety profile of Calquence was consistent with previous findings, with no new safety signals identified. Calquence is already approved for CLL and small lymphocytic lymphoma (SLL) in the US, Japan, and China, and for CLL in the EU and other countries. It is also approved for previously untreated mantle cell lymphoma (MCL) in the US and for MCL post at least one prior therapy in China and other locations.
This recommendation marks a potential expansion in the treatment options for CLL patients in the EU, offering a regimen that could improve outcomes and quality of life. The information is based on a press release statement from AstraZeneca.
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