LONDON (ShareCast) - (Sharecast News) - AstraZeneca announced on Tuesday that it has secured European Commission approval for 'Calquence', or 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 stem cell transplant.
The FTSE 100 company said the decision made Calquence the first Bruton's tyrosine kinase (BTK) inhibitor approved in the European Union for first-line MCL treatment.

It said the approval was based on results from the 'ECHO' phase three trial, which showed that the Calquence combination reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone.

Median progression-free survival was extended by nearly 17 months, reaching 66.4 months versus 49.6 months with the standard treatment.

The trial data were presented at the European Haematology Association Congress in 2024 and published in the *Journal of Clinical Oncology*.

MCL is a rare and aggressive form of non-Hodgkin lymphoma, typically diagnosed at an advanced stage.

In 2024, around 6,000 patients were diagnosed across the UK, France, Germany, Spain and Italy.

AstraZeneca said the safety profile of Calquence in the trial was consistent with previous findings and no new safety signals were identified.

The Calquence regimen is already approved in the US and other countries for the indication, with regulatory reviews ongoing in Japan and several other markets.

"Treatment with the Calquence combination in first-line mantle cell lymphoma demonstrated a significant improvement in progression free survival and a consistent safety profile for patients in the pivotal ECHO trial," said Dave Fredrickson, executive vice-president, of the oncology haematology business unit as AstraZeneca.

"As the first and only BTK inhibitor approved in this indication in the EU, we are proud to provide a much-needed new option to patients living with this difficult disease."

At 0858 BST, shares in AstraZeneca were up 0.82% at 10,842p.

Reporting by Josh White for Sharecast.com.

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