By Fineline Cube 
UK-based pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) announced receiving another indication approval in the European Union (EU) for its Calquence (acalabrutinib), a second-generation selective Bruton tyrosine kinase (BTK) inhibitor. The drug can now be used in combination with bendamustine and rituximab to treat adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. This approval follows the recent nod for Calquence monotherapy for the treatment of adult patients with relapsed or refractory MCL in the region.
Clinical Trial Results
The approval is based on results from the Phase III ECHO study, which showed that the Calquence combination reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. The median progression-free survival (PFS) was 66.4 months for the Calquence group versus 49.6 months in the chemoimmunotherapy group.
Acquisition and Global Registration
AstraZeneca obtained Calquence through the acquisition of a 55% stake in Acerta Pharma for USD 4 billion in 2016. The drug is registered in the US, Japan, China, and other markets, with indications covering B-cell associated hematological tumors such as chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).-Fineline Info & Tech