News | May 27, 2026
Tecan launches direct India operations
The move signals a major expansion milestone for the Swiss laboratory automation company
The move signals a major expansion milestone for the Swiss laboratory automation company
The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India
Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
The validations confirm the completion of the applications and commence the scientific review process
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
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