New PARTNER trial sub-study data show that post-operative ctDNA detection using tumour-informed MRD assays can accurately predict distant recurrence risk in triple-negative breast cancer patients
The companies say the drug has now demonstrated clinical benefit in three separate Phase 3 trials
The safety profile was described as manageable, though not without notable toxicities
The approval is supported by results from the Phase 3 SWOG 1826 trial
The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study,
BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes
Clearance marks major shift beyond chemotherapy
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
The company said the breadth of its showcase reflects “progress from its differentiated oncology pipeline in solid tumors and hematologic malignancies,”
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