FDA expands Enhertu use in early HER2-positive breast cancer
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
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
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
rofitability showed strong momentum, with EBITDA rising 44.9% YoY to Rs. 8,697 million
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