SPRYCEL (Bristol-Myers Squibb Australia Pty Ltd)
Product name
SPRYCEL
Date registered
Evaluation commenced
Decision date
Approval time
212 working days (255)
Active ingredients
dasatinib
Registration type
EOI
Indication
SPRYCEL is now also indicated for the treatment of adults aged 18 years or over:
- with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase.
- with chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
- with Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.
- with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.