LONDON: AstraZeneca said that U.S. regulators had awarded its blood cancer drug acalabrutinib “breakthrough” status for the treatment of patients with mantle cell lymphoma, a rare type of blood cancer.
The U.S. Food and Drug Administration decision clears the way for a speedy regulatory review and comes a day after another of its drugs, Imfinzi, won breakthrough designation for non-metastatic lung cancer.
Both developments represent pluses for AstraZeneca’s cancer portfolio following the initial failure of the key Mystic trial in lung cancer, which triggered the biggest ever daily fall in the company’s shares last week.
AstraZeneca acquired acalabrutinib after buying Acerta Pharma in 2015. The drug is being developed for a variety of cancer types.
(Reporting by Ben Hirschler; editing by Jason Neely)