AstraZeneca Seeks Expanded Use of Blood Cancer Drug Calquence, FDA Grants Priority Review – AstraZeneca (NASDAQ:AZN)

On Thursday, the FDA accepted the approval and granted it priority review AstraZeneca Plcs AZN Supplementary Marketing Authorization Application for Calquence (acalabrutinib) for adult patients with previously untreated mantle cell lymphoma (MCL).

The Prescription Drug User Fee Act date, the date of FDA action on its regulatory decision, is expected to be in the first quarter of 2025.

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL) that occurs when B lymphocytes mutate into malignant cells in an area of ​​the lymph node called the mantle zone.

Also Read: Tagrisso, AstraZeneca's Best-Selling Cancer Drug, Gets FDA Green Light for Another Lung Cancer Indication.

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

The results of the ECHO Phase III study were recently presented during the current oral session at the European Hematology Association (EHA) Hybrid Congress 2024.

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

Adding Calquence to SoC resulted in a median progression-free survival (mPFS) increased by nearly 1.5 years, with an mPFS of 66.4 months for patients treated with Calquence Combination versus 49.6 months with SoC.

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

OS data were immature during this analysis and the study will continue to evaluate OS as a key secondary endpoint.

The ECHO study was conducted during the COVID-19 pandemic. After censoring COVID-19 deaths, PFS continued to improve in both arms, with the CALQUENCE combination reducing the risk of disease progression or death by 36%. In this analysis, the Calquence combination was found to be trending favorably for the operating system, but the operating system data was not yet mature.

Price action: AZN stock was down 1.73% at $78.21 at last check on Thursday.

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