Drug Approval | June 11, 2026
AstraZeneca gets CDSCO nod for Trastuzumab Deruxtecan plus Pertuzumab
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
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
The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
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