BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BioCentury | Jan 1, 2020
Regulation

Fewer FDA approvals in 2019, but a basket of firsts

While the year held fewer approvals of new molecular entities than 2018, it was not short of major achievements. FDA greenlit several drugs with innovative modalities, against novel targets and for diseases that have long...
BC Extra | Dec 21, 2019
Company News

Efficacy data set trastuzumab ADC up for fast approval for third-line breast cancer

Less than two weeks after establishing a new threshold for efficacy in HER2+ breast cancer, Enhertu fam-trastuzumab deruxtecan-nxki has gained accelerated approval from FDA in the indication a mere two months after receiving Priority Review....
BC Extra | Dec 11, 2019
Clinical News

AstraZeneca, Daiichi’s trastuzumab ADC sets new efficacy bar in breast cancer

Trastuzumab deruxtecan from AstraZeneca and Daiichi Sankyo may have established a new threshold for efficacy in HER2+ breast cancer based on pivotal Phase II data. The data were better, in a sicker patient population, than...
BC Extra | Oct 19, 2019
Company News

Oct. 18 Company Quick Takes: AZ-Daiichi, Sanofi, Merck, Lilly and AFTD-Target ALS

Priority Review for breast cancer ADC from Daiichi, AZ  AstraZeneca plc (LSE:AZN; NYSE:AZN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA accepted and granted Priority Review to a BLA for trastuzumab deruxtecan to treat HER2-positive...
BC Innovations | Jul 11, 2019
Product Development

How Zymeworks aims to take on Roche’s $10B HER2 franchise

Zymeworks is going head to head with one of the biggest commercial cancer franchises -- Roche’s Herceptin trastuzumab and Perjeta pertuzumab -- as it pursues clinical proof-of-concept for its protein engineering platform. Pivotal readouts in...
BioCentury | May 24, 2019
Product Development

Why quizartinib hiccup at ODAC shouldn’t derail Daiichi’s 2025 cancer drug goals

FDA's ODAC may have given the thumbs down to Daiichi’s quizartinib, but a stocked pipeline and another ongoing trial of the candidate suggest it’s more of a hiccup than a hurdle in the Japanese pharma’s...
BC Extra | May 8, 2019
Clinical News

AZ, Daiichi planning global submissions for breast cancer ADC

After AstraZeneca paid Daiichi $1.35 billion up front to jointly develop and commercialize the Japanese pharma’s trastuzumab deruxtecan (DS-8201), the partners reported Wednesday that the antibody-drug conjugate met the primary endpoint in the pivotal Phase...
BC Extra | Mar 29, 2019
Company News

Daiichi gets $1.35B up front from AZ in antibody-drug conjugate deal

AstraZeneca will pay Daiichi Sankyo $1.35 billion up front to bolster one of the four platforms of its oncology unit, ADCs. Daiichi Sankyo Co. Ltd. (Tokyo:4568) and AstraZeneca plc (LSE:AZN; NYSE:AZN) announced Friday that they...
BC Week In Review | Oct 17, 2016
Clinical News

DS-8201a: Preliminary Phase I data

Preliminary data from 20 evaluable patients with advanced solid tumors in the dose-escalation part of an open-label, U.S. and Japanese Phase I trial showed that 0.8-8 mg/kg doses of IV DS-8201a every 3 weeks led...
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