logo
Plus   Neg
Share
Email

AstraZeneca And Daiichi Sankyo's Enhertu Approved In EU For Breast Cancer

AstraZeneca Plc. (AZN.L,AZN) and Daiichi Sankyo Company Limited (DSKYF.PK) said that the European Union has conditionally approved Enhertu or trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

The approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial, in which Enhertu showed clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens.

Enhertu is a HER2-directed antibody drug conjugate or ADC. It is the lead antibody drug conjugate in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC scientific platform.

Following EU approval, AstraZeneca will pay Daiichi Sankyo $75 million as a milestone payment for HER2-positive breast cancer.

Daiichi Sankyo and AstraZeneca entered a global collaboration to jointly develop and commercialise Enhertu in March 2019, and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The Australian government has passed the newly amended Media Bargaining Code in the parliament which requires technology giants Facebook and Google to pay for local Australian news content that is shared on their platforms. Regeneron Pharmaceuticals, Inc. (REGN) Thursday said it stopped enrollment into the placebo group for its Phase 3 trial of REGEN-COV in non-hospitalised patients with COVID-19 as per the recommendations from the Independent Data Monitoring Committee or IDMC. According to the company, the IDMC found... Moderna Inc. (MRNA) Thursday reported a fourth-quarter net loss that widened from last year. But quarterly revenues surged from the previous year, driven by increases in grant revenue and product sales. The company raised its 2021 COVID-19 vaccine manufacturing plan.
Follow RTT