The European Commission (EC) has approved a fixed-duration regimen of AstraZeneca’s Bruton’s tyrosine kinase (BTK) selective inhibitor, Calquence (acalabrutinib) plus venetoclax, with or without obinutuzumab, to treat adults with previously untreated chronic lymphocytic leukaemia (CLL).
This decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on outcomes from the pivotal Phase III AMPLIFY trial.
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This trial demonstrated that 77% of subjects treated with Calquence and venetoclax combo and 83% of those who received the therapy along with venetoclax and obinutuzumab remained progression-free after three years.
Calquence combined with venetoclax showed a 35% decrease in disease progression or mortality risk compared to chemoimmunotherapy.
Calquence’s safety and tolerability were found to be consistent with the known safety profile, with no safety issues observed.
Based on the Phase III outcomes, regulatory applications for these regimens are being reviewed in several countries.
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By GlobalDataAstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson stated: “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 currently approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in Japan, the US, China, and for CLL in the European Union (EU) and many other areas.
It was also approved for previously untreated mantle cell lymphoma (MCL) in Europe, the US and other locations, and for treating adults with MCL after a minimum of one previous therapy in China and other countries.
Calquence is part of an extensive clinical development programme, under assessment both as a monotherapy and in conjunction with standard-of-care chemoimmunotherapy for multiple B-cell blood cancers, including diffuse large B-cell lymphoma, MCL and CLL.
