The U.S. Food and Drug Administration granted breakthrough therapy designation to AstraZeneca PLC's acalabrutinib to treat patients with mantle cell lymphoma, a rare type of blood cancer.
The designation was granted to treat patients who have received at least one prior therapy.
The FDA's decision is based on clinical data from the acalabrutinib development program, including data from a phase 2 trial in people with relapsed or refractory mantle cell lymphoma.
The acalabrutinib development program includes both monotherapy and combination therapies for a wide range of blood cancers and solid tumors.
AstraZeneca holds a majority stake interest in Acerta Pharma and its cornerstone asset, acalabrutinib.