AstraZeneca's Calquence approved in EU for first-line CLL treatment
Why we think this is neutral
The RNS announcement provides an update on the European approval of AstraZeneca's Calquence for the treatment of chronic lymphocytic leukemia in the first-line setting. While this is positive news for the company's oncology portfolio, the announcement does not contain any of the mandatory news types that would warrant a more positive or negative sentiment score.
Key Points
- Fixed-duration Calquence-based regimens approved in EU for 1st-line CLL treatment
- AMPLIFY Phase III trial showed Calquence combinations improved progression-free survival vs. standard-of-care
- CLL is the most common type of leukemia in adults, with an estimated 27,000 new diagnoses in key European markets in 2024
Summary
AstraZeneca has received European Commission approval for a fixed-duration regimen of its Calquence (acalabrutinib) drug in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The approval was based on positive results from the AMPLIFY Phase III trial, which demonstrated statistically significant and clinically meaningful improvement in progression-free survival for the Calquence-based regimens compared to standard-of-care chemoimmunotherapy.