AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence, FDA Grants Priority Review

On Thursday, the FDA accepted and granted Priority Review to AstraZeneca Plc’s AZN supplemental marketing application for Calquence (acalabrutinib) for adult patients with previously untreated mantle cell lymphoma (MCL).

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.

Also Read: AstraZeneca’s Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication.

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

Results from the ECHO Phase III trial recently were presented during the late-breaking oral session at the European Hematology Association (EHA) 2024 Hybrid Congress.

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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