The FDA has granted full approval to AstraZeneca’s CALQUENCE (acalabrutinib) combined with bendamustine and rituximab for first-line treatment of adult mantle cell lymphoma (MCL) patients ineligible for autologous hematopoietic stem cell transplantation. This approval, based on the ECHO Phase III trial, follows a Priority Review and converts CALQUENCE’s prior accelerated approval for relapsed/refractory MCL into a full approval. The trial demonstrated a 27% reduction in the risk of disease progression or death compared to standard chemoimmunotherapy, translating to a median progression-free survival (PFS) of 66.4 months versus 49.6 months.

This approval significantly advances treatment options for MCL, a rare and aggressive form of non-Hodgkin lymphoma. Elderly patients, often ineligible for transplantation, now have access to a more effective first-line therapy with improved PFS, potentially delaying disease progression and improving quality of life. This represents a substantial improvement over existing chemoimmunotherapy regimens and potentially sets a new standard of care for this patient population.

The ECHO trial, conducted during the COVID-19 pandemic, showed a median PFS benefit of over 16 months for the CALQUENCE combination. When COVID-19 related deaths were excluded from the analysis, the risk reduction further improved to 36%. This highlights the robustness of the CALQUENCE regimen even amidst the challenges of a global pandemic. The safety profile of CALQUENCE remained consistent with previous findings.

This approval marks a crucial step forward for MCL treatment, providing a new and effective option for patients. The positive ECHO results, combined with the full FDA approval, are expected to increase CALQUENCE’s adoption as a first-line treatment and reinforce its position as a key therapy for B-cell malignancies. Further global regulatory decisions based on the ECHO data are anticipated, potentially expanding access to this promising treatment combination worldwide.

Source link: http://www.businesswire.com/news/home/20250117223765/en/CALQUENCE%C2%AE-acalabrutinib-plus-chemoimmunotherapy-approved-in-the-US-for-patients-with-previously-untreated-mantle-cell-lymphoma

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.