The
US Food and Drug Administration (FDA) has approved new trade name - Caprelsa -
for AstraZeneca's orphan drug vandetanib.
Caprelsa
is indicated as a treatment of symptomatic or progressive medullary thyroid
cancer in patients suffering from unresectable (non-operable) locally advanced
or metastatic disease.
The
FDA approval for Caprelsa was given on the basis of results of ZETA Phase III
trial which demonstrated improvement in progression-free survival (PFS) when
compared to those randomized to placebo.
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