logo
Plus   Neg
Share
Email

AstraZeneca: FDA Grants Priority Review For Trastuzumab Deruxtecan

British drug maker AstraZeneca Plc (AZN.L,AZN) and Japan's Daiichi Sankyo Company, Limited announced that the US Food and Drug Administration has granted Trastuzumab deruxtecan priority review for the treatment of patients with HER2-positive metastatic breast cancer.

The FDA accepted for review the Biologics License Application or BLA for trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate or ADC.

The companies noted that the Prescription Drug User Fee Act or PDUFA date for trastuzumab deruxtecan is set for the second quarter of 2020.

José Baselga, Executive Vice President, Oncology R&D, said, "Trastuzumab deruxtecan has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer who have limited treatment options today. This Priority Review draws on the strength and the consistency of results seen in the Phase I and Phase II trials and is a critical step on the journey to deliver this potential new medicine to patients."

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, added that following the recent regulatory submission in Japan, the company looks forward to working closely with regulatory authorities to bring trastuzumab deruxtecan to patients in the US and Japan as soon as possible.

Trastuzumab deruxtecan was previously granted US FDA Breakthrough Therapy Designation and Fast Track designation.

In was in March 2019 that AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan as a potential new medicine worldwide. The deal excludes Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply in Japan.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Lord & Taylor joined the growing list of U.S. retailers who filed for bankruptcy amid the coronavirus pandemic. Lord & Taylor, one of the oldest department store chains in the U.S., filed for bankruptcy protection in the Eastern Court of Virginia on Sunday. The company operated 38 stores that have remained temporarily closed since March this year due to the pandemic. Thomson International Inc. is recalling Red, Yellow, White, and Sweet Yellow Onions for potential contamination with Salmonella, according to a statement by the U.S. Food and Drug Administration or FDA. The onions are in distribution since May 1, 2020. They were sold to wholesalers, restaurants, and retail stores in all 50 U.S. states, the District of Columbia and Canada. Tyson Foods, Inc. (TSN) reported third quarter adjusted net income per share attributable to company of $1.40 compared to $1.47, a year ago. On average, 12 analysts polled by Thomson Reuters expected the company to report profit per share of $0.94, for the quarter. Analysts' estimates typically exclude...
Follow RTT