US FDA delays AstraZeneca's vandetanib NDA for three months; combo diabetes drug Kombiglyze launched

Anglo-Swedish drug major AstraZeneca (LSE: ANZ) announced last Friday that the US Food and Drug Administration has extended by three months the time to complete its review of the New Drug Application for the firm’s metastatic medullary thyroid cancer (MTC) drug candidate vandetanib.

The news is something of a disappointment, given that an FDA advisory panel issued a positive recommendation on vandetanib, (likely trade name Zactima) for the treatment for this rare type of thyroid cancer, deciding that the risks associated with the drug outweighed its possible benefits in most patients (The Pharma Letter December 3, 2010). The Committee acknowledged that there are patients with MTC in which the risk-benefit profile of vandetanib was acceptable, and voted 10 to 0 in favor of a post-approval study requirement to evaluate other doses.

As part of the review process, the FDA now says that AstraZeneca should submit a Risk Evaluation and Mitigation Strategy (REMS). A proposed REMS was submitted by AstraZeneca and the FDA accordingly extended the Prescription Drug User Fee Act (PDUFA) date from January 7 to April 7, 2011. AstraZeneca said it will continue to work closely with the FDA to support the review of the vandetanib NDA.