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VENCLEXTA, VENCLEXTA STARTING PACK (Abbvie Pty Ltd)
Product name
VENCLEXTA, VENCLEXTA STARTING PACK
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
227 working days (255)
Active ingredients
venetoclax
Registration type
EOI
Indication
Acute Myeloid Leukaemia
VENCLEXTA (film-coated tablet), as part of combination therapy, is now also indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.
This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.