AstraZeneca PLC and Daiichi Sankyo Co. Ltd. said the U.S. Food and Drug Administration granted priority review to their breast cancer drug trastuzumab deruxtecan.
The U.S. regulator accepted the application to review the therapy for treating human epidermal growth factor receptor 2-positive breast cancer which has spread across the body or has metastasized.
The FDA is expected to decide on the therapy's approval by the second quarter of 2020.
In May, trastuzumab deruxtecan was shown to shrink tumors in heavily treated patients with metastatic HER2-positive breast cancer in a phase 2 trial called Destiny-Breast01.
Cambridge, U.K.-based AstraZeneca and Tokyo's Daiichi Sankyo are collaborating on the development and commercialization of trastuzumab deruxtecan, or DS-8201, under a global deal the companies entered in March. The British pharmaceutical giant agreed to pay the Japanese drugmaker $1.35 billion up front, with contingent payments of up to $5.55 billion.
The drug previously received breakthrough therapy and fast track designations from the FDA for treating patients with HER2-positive breast cancer that is locally advanced breast cancer or that has spread to other organs.