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.
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.