US: FDA gives blood cancer drug breakthrough status
AstraZeneca said on Tuesday 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.
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