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The approval was based on positive data from two clinical trials; namely, the Phase III ASCEND trial of Calquence in relapsed or refractory (R/R) CLL patients and a Phase I/II trial in R/R CLL patients in China.
According to the data from the Phase I/II trial, treatment with Calquence offered an overall response rate of 83.3% in study subjects.
ASCEND findings showed that 88% of trial subjects were alive and free from disease progression after 12 months following treatment with Calquence.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “The approval is another step towards our goal of making Calquence available to as many patients as possible and offering physicians a treatment option with a well-established efficacy and tolerability profile.
“Patients with chronic lymphocytic leukaemia are often older and dealing with significant comorbidities, and tolerability is a critical factor in their treatment.”
Calquence is currently available for treating CLL and SLL in the US and Japan while it is indicated for CLL in the R/R and treatment-naïve patients in the EU and other countries globally.
In March 2023, the Chinese regulator granted conditional approval for Calquence for the treatment of MCL in adults who have received a minimum of one earlier therapy.