BioCentury
ARTICLE | Product Development

Jan. 20 Quick Takes: AZ, Daiichi get Enhertu approvals in gastric, breast cancer; plus EdiGene, Merck, Oxford, BMS and Omeros 

January 21, 2021 2:55 AM UTC

Partners AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said HER2-targeted antibody-drug conjugate (ADC) Enhertu fam-trastuzumab deruxtecan-nxki received two additional approvals this week. On Tuesday, FDA approved an sBLA for Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma patients who have received a prior trastuzumab-based regimen. On Wednesday, the European Commission approved Enhertu to treat HER2-positive metastatic breast cancer. 

EdiGene’s CRISPR therapy for β thalassemia moves into clinic
EdiGene Inc. said China’s National Medical Products Administration (NMPA) approved its IND for ET-01, a CRISPR Cas9 gene editing therapy for patients with transfusion-dependent β thalassemia. CRISPR pioneers CRISPR Therapeutics AG (NASDAQ:CRSP) and Editas Medicine Inc. (NASDAQ:EDIT) are also developing CRISPR-based ex vivo therapies for β thalassemia. CRISPR’s CTX001 is in a Phase I/II trial, while Editas’ EDIT-301 is in preclinical development...