The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer. Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype. The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for…
Enhertu slashed risk of disease progression or death by half compared to chemotherapy HER2-low breast cancer
AstraZeneca (LON:AZN) and Daiichi Sankyo’s (OTCMKTS:DSNKY) Enhertu (fam-trastuzumab deruxtecan-nxki) showed a dramatic survival benefit in the pivotal DESTINY-Breast04 Phase 3 study focused on a subset of breast cancer patients. The DNA topoisomerase I inhibitor improved median overall survival by more than six months compared to chemotherapy in the study. In addition, the drug met the…
AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu
The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…
FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer
FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…
Daiichi Sankyo’s valemetostat fares well in lymphoma and leukemia study
Valemetostat, a potential first-in-class drug from Daiichi Sankyo, led to durable tumor response in patients with peripheral T-cell lymphoma (PTCL) and adult T-cell leukemia/lymphoma (ATL) in a Phase 1 study. The company presented highlights from the trial at the European Hematology Association (EHA) 2021 Virtual Congress today. In the study, the objective response rate was…
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the…