Investing.com — AstraZeneca (LON:) in a stock exchange filing on Friday said that the FDA approved its drug Calquence (acalabrutinib) to treat previously untreated mantle cell lymphoma (MCL) in adults who cannot have a stem cell transplant.
This marks an advancement in the treatment landscape for MCL, a rare and aggressive type of non-Hodgkin lymphoma that is often diagnosed in advanced stages.
The Echo Phase III trial showed that the combination therapy improved progression-free survival (PFS) compared to standard chemoimmunotherapy, leading to the FDA approval.
Specifically, patients receiving the Calquence-based regimen had a median PFS of 66.4 months, compared to 49.6 months for those on chemoimmunotherapy alone. The study showed a 27% reduction in the risk of disease progression or death.
“This approval brings a new and effective treatment option to those living with this disease and further reinforces our belief in Calquence as a backbone therapy across multiple blood cancers,” said
Dave Fredrickson, executive vice-president, Oncology Haematology business unit at AstraZeneca in a statement.
The trial’s findings, presented at the 2024 European Hematology Association Congress, further flagged the potential benefits of this approach.
After censoring for COVID-19-related deaths, the reduction in the risk of progression or death improved to 36%.
Although overall survival data remain immature, there was a favorable trend observed in patients receiving the Calquence combination, even as a significant proportion of those in the chemoimmunotherapy arm went on to receive BTK inhibitors following relapse.
The FDA’s approval also converts Calquence’s previous accelerated approval for relapsed or refractory MCL into a full approval.
Originally granted in 2017, the earlier approval was based on data from a separate clinical trial involving patients who had received at least one prior therapy.
MCL, affecting an estimated 21,000 people globally, has limited treatment options. Calquence, the first BTK inhibitor approved for initial MCL treatment in the US, is a crucial advancement, especially for patients ineligible for stem cell transplants. This combination therapy delays disease progression, addressing a critical unmet need.
The safety profile of Calquence in the Echo trial was consistent with previous studies, with no new safety concerns identified. This reinforces the treatment’s position as a tolerable and effective option for patients.
The FDA granted priority review, accelerating the approval process. This submission also utilized project orbis, enabling concurrent regulatory reviews in Australia, Canada, Switzerland, the EU, Japan, and other countries.
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