The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
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
AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care
The new facility combines advanced technology, enhanced capacity, and holistic care, reaffirming HCG’s commitment to accessible, world-class oncology in Gujarat
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
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