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 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)
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
Across more than 85 abstracts, AstraZeneca will showcase 10 approved medicines and 13 potential new therapies
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
The decision is based on the phase 3 DESTINY-Breast11 trial
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development
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