UK-based pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) last week revealed that the US Food and Drug Administration (FDA) has approved its BTK inhibitor Calquence (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. This approval marks a significant advancement in the treatment options available for patients with this rare and aggressive form of cancer.
Approval Background
AstraZeneca obtained Calquence through the acquisition of a 55% stake in Acerta Pharma for USD 4 billion in 2016. The FDA approval was based on results from the Phase III ECHO study, which demonstrated that the combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination, compared to 49.6 months with chemoimmunotherapy alone.
Clinical Impact and Future Implications
This approval not only provides a new treatment option for patients with previously untreated MCL but also converts Calquence’s accelerated approval to a full approval for adult patients with MCL who have received at least one prior therapy. The drug was initially granted accelerated approval by the FDA in October 2017 and has since obtained approvals for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in 2019. The expanded indication underscores AstraZeneca’s commitment to advancing cancer treatments and improving patient outcomes.-Fineline Info & Tech
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