6th May 2025 09:41
(Alliance News) - AstraZeneca PLC on Tuesday said Calquence plus chemoimmunotherapy has been approved in the European Union for previously untreated mantle cell lymphoma in adults.
The Cambridge-based pharmaceuticals company said the decision follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from the Echo phase 3 trial.
This showed that Calquence, with bendamustine and rituximab, reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Median progression-free survival was 66.4 months for patients treated with the Calquence combination, versus 49.6 with chemoimmunotherapy alone.
MCL is a rare and aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage.
The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified, AstraZeneca said in a statement.
"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," said Dave Fredrickson, executive vice president, Oncology Haematology Business Unit, AstraZeneca.
Calquence plus bendamustine and rituximab is approved in the US, and several other countries, based on the Echo trial results. Regulatory applications are also currently under review for this indication in multiple countries including Japan.
The approval follows the recent approval in the EU for Calquence as a monotherapy, for the treatment of adult patients with relapsed or refractory MCL.
Shares in AstraZeneca were up 0.9% at 10,846.31 pence each in London on Tuesday morning.
By Jeremy Cutler, Alliance News reporter
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