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AstraZeneca's Calquence: Pioneering BTK Inhibitor for 1st-Line MCL in EU Approval Report

$AZN
Form 6-K
Filed on: 2025-03-31
Source
AstraZeneca's Calquence: Pioneering BTK Inhibitor for 1st-Line MCL in EU Approval Report

Here are the key insights from the financial report section regarding AstraZeneca's Calquence:

Approval Recommendation

  • Calquence (acalabrutinib) has been recommended for approval in the European Union (EU) as the first and only Bruton's tyrosine kinase (BTK) inhibitor for the treatment of 1st-line mantle cell lymphoma (MCL) in adult patients who are not eligible for autologous hematopoietic stem cell transplantation.

Trial Results

  • The recommendation is based on results from the ECHO Phase III trial which showed a significant improvement in progression-free survival (PFS):
  • PFS Improvement: Calquence combined with bendamustine and rituximab resulted in a median PFS of 66.4 months, compared to 49.6 months for standard chemoimmunotherapy.
  • Risk Reduction: There was a 27% reduction in the risk of disease progression or death (hazard ratio [HR] 0.73; 95% CI 0.57-0.94; p=0.016).

Expert Opinions

  • Martin Dreyling, MD, highlighted the substantial benefits of the Calquence combination for managing this aggressive cancer, particularly for older patients needing a balance of efficacy and tolerability.
  • Susan Galbraith, Executive Vice President at AstraZeneca, emphasized that this recommendation could transform the standard of care in Europe for patients with MCL.

Market Context

  • MCL is a rare and aggressive form of non-Hodgkin lymphoma, with more than 6,000 patients diagnosed in key European markets in 2024.
  • The safety profile of Calquence remained consistent with previous data, and no new safety signals were identified during the trial.

Current Status

  • Calquence is already approved in the US and several other countries for this indication, with regulatory applications under review in Japan and other markets.

Conclusion

This report showcases AstraZeneca's strategic advancement in oncology, particularly in the treatment of MCL, with the potential for Calquence to significantly alter treatment paradigms if the EU approval is granted.