AstraZeneca's Enhertu wins additional indication in earlier stage breast cancer
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The U.S. FDA has granted an additional approval for AstraZeneca's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) as a second-line treatment for HER2-positive metastatic breast cancer.
The antibody drug conjugate ("ADC") was already approved in a later stage breast cancer setting as well as for second-lineÂ  HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Based on phase 3 data, Enhertu was added toÂ NCCN Clinical Practical Guidelines in OncologyÂ as the preferred regimen as second-line therapy for recurrent unresectable (local or regional) or Stage IV HER2-positive disease.
AstraZeneca Thursday also released new data on Farxiga (dapaglifloxzin) forÂ reducing the risk of death or heart failure.