Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more prior treatment regimens. This marks Enhertu’s third indication approval in the Chinese market.
Previously, Enhertu was approved for treating unresectable or metastatic HER2-positive breast cancer in adults who have received one or more anti-HER2 therapies, as well as for adult patients with unresectable or metastatic HER2-low expressed breast cancer (IHC 1+ or IHC 2+/ISH -) after at least one systemic treatment during metastatic disease or recurrence within six months post-adjuvant chemotherapy.
The conditional approval for GC/GEJ is supported by positive outcomes from the DESTINY-Gastric06 Phase II trial, where Enhertu (administered at 6.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 28.8%, as evaluated by independent central review. The median progression-free survival (PFS) was reported at 5.7 months. The safety profile of Enhertu in this trial aligned with previous studies in gastric cancer, revealing no new safety concerns.- Flcube.com
