Zaltrap FDA approved
August 7, 2012
THE US Food and Drug
Administration has approved
Zaltrap (ziv-aflibercept) Injection for
Intravenous Infusion, in
combination with 5-fluorouracil,
leucovorin, irinotecan (FOLFIRI), for
patients with metastatic colorectal
cancer (mCRC) that is resistant to or
has progressed following an
oxaliplatin-containing regimen.
The drug was approved following
a Priority Review by the FDA.
“Colorectal cancer is one of the
deadliest cancers and is responsible
for more than half a million deaths
globally each year,” said Debasish
Roychowdhury, Senior VP and
Head, Sanofi Oncology.
“Sanofi looks forward to making
Zaltrap available as soon as possible
to patients with metastatic
colorectal cancer previously treated
with an oxaliplatin-containing
regimen,” he added.
The approval is based on data
from the pivotal Phase III VELOUR
trial which involved 1,226 patients
with mCRC who previously had
been treated with an
oxaliplatin-containing regime.
The study found that in patients
previously treated with an
oxaliplatin containing regimen,
adding Zaltrap to Folfiri significantly
improved median survival from
12.06 months to 13.50 months, and
resulted in significant improvement
in progression-free survival from
4.67 months to 6.90 months, whilst
a 24% relative risk reduction was
also observed.
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