THE Therapeutic Goods
Administration has approved
Yervoy (ipilimumab) 3mg/kg, as a
monotherapy for the treatment of
patients with unresectable
(inoperable) or metastatic
melanoma who have failed or are
intolerant to prior therapy.
The approval is based on a trial
involving 676 patients with
previously treated treated,
unresectable Stage IIIc or Stage IV
melanoma.
Results of the study showed
survival rates at 1 and 2 years for
patients treated in the YERVOY arm
were 46 percent and 24 percent,
respectively, compared to 25
percent and 14 percent at the same
time points in the gp100 arm.
Yervoy is the first TGA approved
therapy for unresectable or
metastatic melanoma to
demonstrate a statistically
significant improvement in overall
survival.
The TGA approval follows hot on
the heels of its US approval by the
Food and Drug Administration.The above article was sent to subscribers in Pharmacy Daily's issue from 06 Jul 11 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 06 Jul 11
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