AstraZeneca announced the US FDA approval of Calquence (acalabrutinib) combined with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for stem cell transplantation. This marks the first BTK inhibitor approved for first-line treatment of MCL in the US. The decision was based on the ECHO Phase III trial, which showed significant improvement in progression-free survival compared to chemoimmunotherapy alone, extending it by more than 16 months.

The trial highlighted the combination's ability to reduce the risk of disease progression or death by 27% compared to standard treatment, with a median progression-free survival of 66.4 months versus 49.6 months. The safety profile of Calquence was consistent with previous data, and no new safety concerns were identified.

This approval also converted Calquence’s prior accelerated approval for MCL to full approval. Regulatory submissions for the combination therapy are under review in other countries, including Australia, Canada, Switzerland, the EU, and Japan. Calquence, a selective BTK inhibitor, has been used to treat over 85,000 patients globally and is approved for various B-cell blood cancers. This milestone reinforces AstraZeneca’s commitment to advancing cancer treatment.