LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Friday said that the Food and Drug Administration (FDA) has approved Calquence plus chemoimmunotherapy combination bendamustine and rituximab for the treatment of patients with previously untreated mantle cell lymphoma (MCL), a rare type of blood cancer.
The approval was based on results from ECHO Phase III trial which showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27 percent compared to standard-of-care chemoimmunotherapy.
The company also noted that this approval converts Calquence's accelerated approval granted in October 2017 to a full approval for patients with MCL who are treated with at least one prior therapy.
Calquence plus chemoimmunotherapy is under review by regulatory authorities in many parts of the world including EU, Australia, Canada, Switzerland, Japan, among others.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
