POLIVY (Roche Products Pty Ltd)
Product name
POLIVY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 working days (255)
Active ingredients
polatuzumab vedotin
Registration type
NCE/NBE
Indication
POLIVY (powder for injection) in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available