EU approves Calquence combination for untreated CLL

UK – The European Commission (EC) has granted approval for a new fixed-duration treatment regimen involving AstraZeneca’s selective Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib).

This regimen, used in combination with venetoclax, and optionally with obinutuzumab, is now approved for adults diagnosed with previously untreated chronic lymphocytic leukemia (CLL).

This significant regulatory decision follows a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP).

The approval is directly supported by the compelling outcomes observed in the pivotal Phase III AMPLIFY trial.

The AMPLIFY trial demonstrated strong efficacy. A notable 77% of patients receiving the Calquence and venetoclax combination remained free of disease progression after three years.

This figure rose to 83% for those who received the triple therapy, including obinutuzumab. Furthermore, the combination of Calquence and venetoclax showed a 35% reduction in the risk of disease progression or mortality when compared to traditional chemoimmunotherapy approaches.

Safety data from the trial indicated that Calquence maintained a consistent and well-understood safety profile, with no new safety concerns identified.

Based on these positive Phase III results, regulatory applications for these treatment regimens are currently under review in several other countries globally.

Mr. Dave Fredrickson, Executive Vice-President of AstraZeneca’s Oncology Hematology Business Unit, commented on the approval: “Today’s approval brings a new fixed-duration treatment option to patients with previously untreated CLL across Europe.

“Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer.”

Calquence is already approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in regions such as Japan, the United States, and China. Within the European Union and many other territories, it holds approval specifically for CLL.

Additionally, Calquence has received approval for the treatment of previously untreated mantle cell lymphoma (MCL) in Europe, the United States, and other regions, as well as for treating adults with MCL who have received at least one prior therapy in China and other countries.

Calquence is also a key component of an extensive clinical development program. Its efficacy is being evaluated both as a standalone therapy and in conjunction with standard-of-care chemoimmunotherapy across various B-cell blood cancers, including diffuse large B-cell lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.