UK pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a monotherapy. This marks the third indication approval for the second-generation BTK inhibitor in China.
Clinical Trial Results The latest NMPA approval is based on results from the Phase III ChangE study, a randomized, multi-center, open-label Asia Phase III study led by AstraZeneca’s China unit. The study demonstrated that acalabrutinib significantly reduced the risk of disease progression or death in newly diagnosed CLL patients by 92% (HR=0.08, P<0.0001) compared to the combination therapy of chlorambucil and rituximab (C+R). The median progression-free survival (PFS) for acalabrutinib was not reached versus 15.5 months for the C+R group, with a 24-month PFS rate of 92% compared to 25% for C+R, showing both statistical significance and clear clinical benefits.
Acquisition Background AstraZeneca obtained acalabrutinib through the acquisition of a 55% stake in Acerta Pharma for USD4 billion in 2016. The drug was first approved in China in March 2023.-Fineline Info & Tech
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