A US Food and Drug Administration advisory panel has issued a positive recommendation on vandetanib, (likely trade name Zactima) which is being developed by Anglo-Swedish drug major AstraZeneca (LSE: AZN) for the treatment for a rare type of thyroid cancer, deciding that the risks associated with the drug outweighed its possible risks in most patients.
The FDA Oncologic Drugs Advisory Committee meeting was convened to discuss the New Drug Application for AstraZeneca's, (LSE: AZN) vandetanib for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC). The Committee was asked to discuss whether the indication should be limited to patients with progressive, symptomatic MTC. They were also asked to comment on whether there are any other subgroups that may be appropriate for treatment with vandetanib in light of the risk-benefit profile. The Committee was not asked to vote on this issue.
Unanimous vote for post-approval study on dosage
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