July 2008 PBAC Outcomes - Deferrals

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July 2008 PBAC Outcomes - Deferrals

Drug and Form

Drug and Type

Listing Requested by Sponsor

PBAC Outcome and Comment

Dasatinib, tablet, 
20 mg, 50 mg, 70 mg, (Sprycel®)

Bristol-Myers Squibb Pharmaceuticals

Minor submission
Chronic myeloid leukaemia (CML)
Acute lymphoblastic leukaemia (ALL)
To request the removal of the 140 mg/day dosage restriction for both CML and ALL. Deferred, pending further information.
Sponsor’s comments: The sponsor will continue to work with the PBAC to reach a satisfactory outcome.