AstraZeneca's Calquence Gains FDA Approval for Lymphoma
AstraZeneca's Exciting New Approval for Calquence
Recently, the U.S. Food and Drug Administration (FDA) has granted approval for AstraZeneca's Calquence (acalabrutinib), a groundbreaking treatment for adult patients with previously untreated mantle cell lymphoma (MCL) who cannot undergo autologous hematopoietic stem cell transplantation. This approval marks a significant stride in the medical field.
Transformative Findings from Phase III Trials
The exciting news was shared with the public recently, showcasing Calquence as the first Bruton's tyrosine kinase (BTK) inhibitor approved for first-line treatment of MCL in the United States. This noteworthy decision follows compelling results from the ECHO Phase III trial, which highlighted a remarkable enhancement in progression-free survival (PFS) when comparing treatments. The trial predominantly involved patients aged 65 and older, demonstrating that those on the combination regimen enjoyed a median PFS of 66.4 months, contrasting sharply with 49.6 months for those receiving conventional chemoimmunotherapy. This innovative combination reduced the risk of disease progression or death by 27%.
Expert Insights on the New Regimen
Michael Wang, MD, the principal investigator for the clinical trial, emphasized the advantages of this new regimen. He noted its potential to become the new standard of care by striking a harmonious balance between effectiveness and tolerability, which is especially vital for the older patient population.
Safety and Robust Trial Design
The safety profile of Calquence remained as expected, without presenting any fresh safety concerns. Furthermore, the design of the ECHO trial was commendable, allowing continuity throughout the challenges posed by the COVID-19 pandemic; modifications were made to ensure that analyses considered the impact of COVID-19-related fatalities.
Transition from Accelerated Approval
This latest FDA decision transforms the prior accelerated approval status of Calquence, which was initially granted in 2017 for patients who had previously received at least one therapy, into a full approval. This change heralds a new era for MCL treatment options.
Global Collaborative Efforts
The ECHO trial's extensive reach, involving 27 countries, showcases a collaborative global initiative aimed at enhancing treatment for this aggressive non-Hodgkin lymphoma subtype. Although MCL accounts for a small portion of non-Hodgkin lymphoma cases, it often presents at advanced stages, underlining the urgent need for effective therapies.
Project Orbis and International Reviews
Under Project Orbis, Calquence's approval enables concurrent reviews across participating countries, with regulatory authorities in Australia, Canada, and Switzerland currently examining the therapy for the same indication. Further submissions for review are also ongoing in the European Union, Japan, and other regions based on the findings from the ECHO trial.
Frequently Asked Questions
What is Calquence used for?
Calquence is used for the treatment of adult patients with untreated mantle cell lymphoma who are ineligible for stem cell transplantation.
How does Calquence work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor that helps to slow the progression of B-cell malignancies by blocking specific signals necessary for cancer cell survival.
What were the results of the ECHO Phase III trial?
The ECHO trial indicated a significant increase in progression-free survival, demonstrating a median PFS of 66.4 months with Calquence compared to 49.6 months with standard treatment.
What does full approval mean for Calquence?
Full approval allows Calquence to be marketed without restrictions, enhancing patient access to this important therapy.
Where else is Calquence approved?
Calquence is currently under review in countries such as Australia, Canada, Switzerland, the EU, and Japan for similar indications.
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