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AstraZeneca PLC (LON:AZN) said its drug Calquence has been approved in the EU to treat chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
The green light follows positive results from two Phase III clinical trials and a recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July.
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Calquence is approved for the treatment of CLL in several countries worldwide and in the US for small lymphocytic lymphoma, which affects the blood cells that fight infections.
It is also approved for the treatment of adults with mantle cell lymphoma, another type of blood cancer, who have received at least one prior therapy in the US and several other countries but not in Europe.
The drug is a next-generation, selective inhibitor of BTK, which is an enzyme that promotes the proliferation and survival of leukemic cells.
“This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options,” said Dave Fredrickson, executive vice president at the pharma company’s oncology business unit.
“As our first European approval in blood cancers, Calquence provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with chronic lymphocytic leukaemia.”
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