AstraZeneca Gets Approval For Oncology Drug To Treat Mantle Cell Lymphoma In EU: But Retail Sentiment Dips

The approval is based on positive results from a phase 3 trial, which demonstrated that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.

Shares of AstraZeneca (AZN) rose 1% on Tuesday morning after it announced that its Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

The combination caters to patients not eligible for an autologous stem cell transplant.

The approval is based on positive results from a phase 3 trial, which demonstrated that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma. AstraZeneca estimates 6,000 patients were diagnosed with MCL in the U.K., France, Germany, Spain, and Italy in 2024.

Calquence plus bendamustine and rituximab has already been approved in the U.S. and several other countries for the same treatment.

The company has also applied for regulatory approval for the combination in Japan and several other countries to treat MCL.

Calquence brought in $762 million in revenue for AstraZeneca in the first quarter of 2025, accounting for 6% of its total medicine revenue.

The company’s overall oncology medicine segment revenue jumped 10% to $5.64 billion in the three months through the end of March.

On Stocktwits, retail sentiment around AstraZeneca fell from ‘bullish’ to ‘bearish’ over the past 24 hours while message volume fell from ‘normal’ to ‘low’ levels.

AZN stock is up by about 10% this year but down by nearly 4% over the past 12 months.

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