AstraZeneca's Calquence recommended for EU approval in first-line mantle cell lymphoma
Why we think this is neutral
This RNS announcement provides an update on the regulatory progress of AstraZeneca's Calquence in the treatment of mantle cell lymphoma. While the news is positive, as Calquence has been recommended for approval in the EU, it does not fall under any of the mandatory news categories that would require a more detailed analysis. Therefore, a neutral sentiment score is appropriate.
Key Points
- Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma
- Recommendation based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
- Calquence is approved in this setting in the US and several other countries
Summary
AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation. The recommendation is based on the positive results from the ECHO Phase III trial, which demonstrated over 16 months of progression-free survival improvement compared to chemoimmunotherapy alone. Calquence is already approved in this setting in the US and several other countries.