Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Friday that Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous haematopoietic stem cell transplantation.

This approval was based on the ECHO Phase III trial, which demonstrated a significant improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy.

MCL is a rare and aggressive form of non-Hodgkin lymphoma. The ECHO trial showed that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone. Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 months with chemoimmunotherapy alone.

The FDA also converted Calquence's accelerated approval to full approval for adult patients with MCL treated with at least one prior therapy.

Calquence is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved for the first-line treatment of MCL in the United States. Regulatory submissions for this indication are also under review in several other countries.