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news.The US Food and Drug Administration (FDA) has approved new trade name - Caprelsa - for AstraZeneca's orphan drug vandetanib.
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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.
AstraZeneca Oncology executive director Eric Vogel said they choose to launch the drug as vandetanib without waiting for a trade name approval because there were no other FDA-approved medicines available for people with this rare type of thyroid cancer.