WASHINGTON - The U.S. Food and Drug Administration has granted approval to AstraZeneca (NASDAQ:AZN)'s Calquence (acalabrutinib), in combination with bendamustine and rituximab, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
This decision, announced today, marks the first approval of a Bruton's tyrosine kinase (BTK) inhibitor for the first-line treatment of MCL in the United States.
The approval comes after the ECHO Phase III trial results demonstrated a significant improvement in progression-free survival (PFS) when compared to chemoimmunotherapy alone. The trial, which enrolled patients aged 65 and over, showed that the Calquence combination extended median PFS to 66.4 months, versus 49.6 months for those on chemoimmunotherapy, reducing the risk of disease progression or death by 27%.
Michael Wang, MD, who served as the principal investigator for the trial, highlighted the regimen's potential as a new standard of care that balances efficacy and tolerability, particularly for older patients.
The safety profile of Calquence was consistent with previous findings, showing no new safety concerns. The trial's robust design included a continuation through the COVID-19 pandemic, with certain analyses adjusted to account for COVID-19 related deaths.
This approval also converts the accelerated approval of Calquence, initially granted in October 2017 for MCL patients treated with at least one prior therapy, to a full approval.
The ECHO trial's international scope, spanning 27 countries, underscores the global effort to improve treatment for this aggressive form of non-Hodgkin lymphoma. MCL represents a small percentage of NHL cases but is often diagnosed at an advanced stage, necessitating new effective treatments.
Calquence's approval under Project Orbis facilitates concurrent reviews among participating countries, with regulatory authorities in Australia, Canada, and Switzerland currently reviewing the therapy for the same indication. Further submissions are under review in the EU, Japan, and other countries, based on the ECHO trial results.
This information is based on a press release statement from AstraZeneca.
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