AstraZeneca's Calquence Gains Full FDA Approval for MCL

AstraZeneca's Calquence Approved for Mantle Cell Lymphoma

AstraZeneca has recently announced the approval of its drug Calquence (acalabrutinib) by the FDA for the treatment of untreated mantle cell lymphoma (MCL) in adults who are ineligible for a stem cell transplant.

Significance of the Approval

This approval is a significant milestone in the treatment of MCL, which is a rare and aggressive form of non-Hodgkin lymphoma often diagnosed at advanced stages.

Clinical Trial Success

The Echo Phase III trial demonstrated that patients receiving the Calquence-based regimen achieved a median progression-free survival (PFS) of 66.4 months, compared to 49.6 months for those on standard chemotherapy. This represents a remarkable 27% reduction in the risk of disease progression or mortality.

Expert Commentary

Dave Fredrickson, executive vice-president of AstraZeneca's Oncology Haematology business unit, stated, "This approval brings a new and effective treatment option to those living with this disease and reinforces our commitment to Calquence as a foundational therapy for various blood cancers."

Trial Findings and Implications

The findings of the trial were showcased at a significant European Hematology Association Congress, further underscoring the potential of this therapeutic approach. After adjusting for COVID-19 related fatalities, the reduction in risk of progression or death improved to 36%.

Patient Outlook

While overall survival data are still being collected, trends indicate a positive outlook for patients receiving the Calquence combination treatment, especially as many patients in the chemotherapy group subsequently received BTK inhibitors post-relapse.

Transition from Accelerated to Full Approval

This recent FDA approval also formalizes Calquence’s previous accelerated approval status for relapsed or refractory MCL, solidifying its role in the treatment arsenal against this aggressive lymphoma.

Historical Context

Originally approved in 2017 based on earlier clinical trials, Calquence's full approval reflects the growing body of evidence validating its efficacy and safety.

Addressing a Critical Need

Affecting around 21,000 individuals globally, MCL presents limited treatment avenues. Calquence leads as the first BTK inhibitor authorized for upfront MCL treatment in the U.S., making it a pivotal development for those who cannot undergo stem cell transplantation. This combined therapy is essential in extending progression-free survival, which is a vital requirement for patients in challenging circumstances.

Safety and Efficacy Data

The safety profile of Calquence in the Echo trial aligned with previous studies, showing no new safety issues. This consistency fortifies Calquence’s position as a reliable and potent therapeutic choice for patients.

Expedited Approval Process

The FDA's designation of priority review significantly expedited the approval process for Calquence. Additionally, AstraZeneca's submission benefited from the Project Orbis initiative, facilitating simultaneous reviews across multiple countries including Australia, Canada, and members of the European Union.

Frequently Asked Questions

What is Calquence used for?

Calquence is primarily used to treat mantle cell lymphoma, particularly in adults who cannot undergo stem cell transplants.

How does Calquence compare to traditional therapies?

Clinical trials have shown that Calquence offers improved progression-free survival compared to standard chemotherapy approaches.

What was the outcome of the Echo Phase III trial?

The trial indicated a significant reduction in disease progression and death risk, marking a promising advancement in MCL treatment.

Who can benefit from Calquence?

Calquence is especially beneficial for patients diagnosed with untreated mantle cell lymphoma who are not eligible for stem cell transplants.

What safety concerns are associated with Calquence?

Calquence has demonstrated a safety profile consistent with earlier studies, without new significant safety concerns arising in recent trials.

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