FDA Approved Calquence (acalabrutinib) for Mantle Cell Lymphoma

On Jan. 16, 2025, 

• FDA granted traditional approval to AstraZeneca’s Calquence (acalabrutinib; BTK inhibitor) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
• FDA converted single agent acalabrutinib for previously treated MCLfrom accelerated to traditional approval. Acalabrutinib received accelerated approval for this indication in 2017.

Efficacy:

ECHO (NCT02972840) is a randomized, double-blind, placebo controlled, multicenter trial in 598 patients with untreated MCL who were ≥65 years of age and not intended to receive HSCT.  

Progression-free survival (PFS):  Median PFS was 66.4 months (95% CI: 55.1, not estimable) in the acalabrutinib plus BR arm and 49.6 months (95% CI: 36.0, 64.1) in the placebo plus BR arm. (hazard ratio 0.73 [95% CI: 0.57, 0.94], p-value 0.016)

Safety:

Serious adverse reactions occurred in 69% of patients with acalabrutinib plus BR, and fatal adverse reactions occurred in 12%. 

Expedited Programs:

• Project Orbis (FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Switzerland’s Swissmedic. Reviews are ongoing at the other regulatory agencies.)
• Priority Review 
• Orphan drug designation
• Assessment Aid was used