trending Market Intelligence /marketintelligence/en/news-insights/trending/2UWMnPwk1NRi-UhSMvBV5Q2 content esgSubNav
In This List

AstraZeneca-Daiichi Sankyo breast cancer drug gets US FDA priority tag

Blog

Insight Weekly: Layoffs swell; energy efficiency PE deals defy downturn; 2023 global risk themes

Blog

Insight Weekly: Energy crisis cripples Europe; i-bank incomes rise; US holiday sales outlook

Blog

Japan M&A By the Numbers: Q3 2022

Blog

Insight Weekly: Reviving nuclear power; 2023 outlook for US financials; PE funds fuel EV sector


AstraZeneca-Daiichi Sankyo breast cancer drug gets US FDA priority tag

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.

SNL Image