GAZYVA, a new anti-CD20 monoclonal antibody, is now Therapeutic Goods Administration (TGA) approved for the treatment of patients with previously untreated CLL in combination with Chlorambucil in Australia. It is NOT on the Pharmaceutical Benefits Scheme (PBS).
In the CLL11 GAZYVA study, GAZYVA + Chlorambucil:
* More than doubled Progression Free Survival (PFS) vs Chlorambucil alone (26.7 vs 11.1 months)
* Provided nearly 1-year improvement in PFS vs MabThera (Rituximab) + Chlorambucil (26.7 vs 15.2 months)
This follows FDA approval 7 months ago:
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