UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior treatment. This marks a significant expansion of Calquence’s indication in China, following its previous approval for adult mantle cell lymphoma (MCL) patients in March this year.
AstraZeneca’s Acquisition and Calquence’s Advantages
AstraZeneca acquired Calquence through a significant investment, purchasing 55% stakes in Acerta Pharma for USD 4 billion in 2016. The drug has demonstrated better selectivity and lower toxicity compared to the first-generation BTK inhibitor ibrutinib, resulting in fewer discontinuations due to adverse events. Calquence was first approved in the US for the treatment of MCL in 2017 and later gained approval for CLL and SLL in 2019, with subsequent market approvals in Europe and Japan.
Supporting Studies and Global Approvals
The latest NMPA approval is supported by positive results from the global multi-center, randomized, controlled Phase III ASCEND study and a China Phase I/II single-arm pivotal study. Both studies have shown Calquence’s excellent efficacy and good safety profile, reinforcing its position as a preferred treatment option for patients with CLL and SLL.-Fineline Info & Tech
