China Approves AstraZeneca's Calquence for Treating Chronic Lymphocytic Leukemia

Calquence, a next-generation, selective Bruton's tyrosine kinase (BTK) inhibitor developed by AstraZeneca, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy. The approval by the National Medical Products

Administration (NMPA) was based on positive results from two clinical trials, including the ASCEND phase III trial of Calquence versus investigator's choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) for patients with relapsed or refractory (R/R) CLL and an open-label, single-arm phase I/II trial in China for patients with R/R CLL. CLL is the most common type of adult leukaemia worldwide, accounting for approximately 6.4% of B-cell non-Hodgkin lymphoma patients in China.

"Today's 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," said Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca. Patients with chronic lymphocytic leukaemia are often older and have multiple comorbidities, so tolerability is critical in their treatment." Additionally, results from a phase I/II trial in Chinese adults with R/R CLL showed Calquence achieved an overall response rate (ORR) of 83.3%.

At a median follow-up of 20.2 months, median progression-free survival (PFS) was not reached and the 12-month and 18-month PFS rates were 90.7% and 78.8%, respectively. The safety and tolerability of Calquence in these trials were consistent with that observed in previous clinical trials. By targeting haematologic conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.