Trastuzumab deruxtecan (DS-8201a) is an antibody-drug conjugate used for the treatment of metastatic HER2+ breast cancer that is refractory to anti-HER2 therapy such as T-DM1, however, there is a lack of knowledge on acquired or innate resistance to the drug.
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial.
HONG KONG – Daiichi Sankyo Co. Ltd. has won regulatory approval for Enhertu (trastuzumab deruxtecan) in Japan based on a pivotal phase II trial alone. The HER2-directed antibody-drug conjugate has been approved for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency. Daiichi's Enhertu (trastuzumab deruxtecan), the subject of a $6.9 billion deal with Astrazeneca, won accelerated approval for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Eisai's Dayvigo (lemborexant) was approved to treat insomnia. Intra-Cellular's Caplyta (lumateperone) was approved to treat schizophrenia. Allergan’s Ubrelvy (ubrogepant) became the first of a relatively new class of drugs to be approved for the acute treatment of migraine.