EC Approves AstraZeneca's Acalabrutinib Combo for CLL

The European Commission (EC) has recently given its approval for a fixed-duration treatment regimen involving AstraZeneca's Bruton’s tyrosine kinase (BTK) selective inhibitor, Calquence (acalabrutinib), used in combination with venetoclax, with or without the addition of obinutuzumab. This approval is specifically for adults who are newly diagnosed with chronic lymphocytic leukaemia (CLL). This decision comes on the heels of a positive recommendation from the Committee for Medicinal Products for Human Use, grounded in findings from the pivotal Phase III AMPLIFY trial.

The AMPLIFY trial demonstrated compelling results: 77% of patients treated with the combination of Calquence and venetoclax, and 83% of those receiving the treatment alongside venetoclax and obinutuzumab, managed to remain free from disease progression over a three-year period. The combination of Calquence with venetoclax alone was associated with a 35% decrease in the risk of disease progression or mortality in comparison to the traditional chemoimmunotherapy approach. Importantly, the safety profile of Calquence remained consistent with previous findings, showing no new safety issues.

In light of these promising Phase III results, regulatory submissions for these treatment regimens are currently under evaluation in various countries around the globe. Dave Fredrickson, executive vice-president of AstraZeneca's oncology haematology business unit, emphasized the significance of this approval, stating that it introduces a novel fixed-duration treatment option for CLL patients across Europe. This regimen, comprising Calquence and venetoclax, stands as the first all-oral combination treatment approved in the European Union that includes a second-generation BTK inhibitor. This offers patients and healthcare providers increased flexibility in managing this challenging blood cancer.

Calquence is already recognized for its efficacy in treating chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in countries such as Japan, the US, China, and within the European Union, among other regions. Additionally, it has received approval for the treatment of previously untreated mantle cell lymphoma (MCL) in Europe, the US, and beyond, as well as for adults with MCL who have undergone at least one prior therapy in China and several other countries.

Calquence is a critical component of an extensive clinical development program, being evaluated both as a standalone therapy and in combination with standard chemoimmunotherapy treatments for various B-cell blood cancers. These include diffuse large B-cell lymphoma, mantle cell lymphoma (MCL), and chronic lymphocytic leukaemia (CLL).

The approval of this new regimen marks a significant advancement in the treatment landscape for CLL, offering a promising new option for patients who have yet to receive treatment for this disease. This development underscores AstraZeneca's commitment to expanding therapeutic options and improving outcomes for individuals affected by these complex blood cancers.