The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.

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It is estimated that more than 27,500 people are living with MCL worldwide.

In the trial, Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemoimmunotherapy.

Adding Calquence to SoC provided almost 1.5 years of additional median progression-free survival (mPFS) with mPFS of 66.4 months for patients treated with the Calquence combination versus 49.6 months with SoC.

Overall survival (OS) showed a favorable trend for the Calquence combination compared to SoC chemoimmunotherapy.

The OS data were not mature during this analysis, and the trial will continue to assess OS as a key secondary endpoint.

The ECHO trial was conducted during the COVID-19 pandemic. After censoring COVID-19 deaths, the PFS was further improved in both arms, with the CALQUENCE combination reducing the risk of disease progression or death by 36%. A favorable trend was seen for OS in this analysis for the Calquence combination, but OS data were not mature.

Price Action: AZN stock is down 1.73% at $78.21 at last check Thursday.

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