FDA approves new trade name for AstraZeneca 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.

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.