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BLINCYTO (Amgen Australia Pty Ltd)
Product name
BLINCYTO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 (255 working days)
Active ingredients
blinatumomab
Registration type
EOI
Indication
Blincyto is indicated for the treatment of B-cell precursor acute lymphoblastic leukaemia (ALL) in the consolidation phase:
- in combination with chemotherapy in patients with Philadelphia chromosome negative disease;
- in combination with a tyrosine kinase inhibitor in patients with Philadelphia chromosome positive disease, who are unable to receive chemotherapy.