AstraZeneca's vandetanib and GSK/XenoPort's Horizant get US approval

There was good news for UK-headquartered pharma companies - AstraZeneca (LSE: AZN) and GlaxoSmithKline (LSE: GSK), as well as the latter’s partner XenoPort (Nasdaq: XNPT, (which saw its shares rocket 57% to $10 in extended trading yesterday) - with announcements of US Food and Drug Administration approval for each of their investigational drugs.

The FDA cleared AstraZeneca’s vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. The decision follows a positive opinion from an advisory panel late last year (The Pharma Letter December 3, 2010), when it was suggested that the likely trade name for the drug would be Zactima. The FDA extended its review of the product, which had been given orphan drug status, by three months.

About 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease, according to the National Cancer Institute. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer; its estimated incidence in the United States for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer.
The drug targets medullary thyroid cancer’s ability to grow and expand. There are currently no FDA-approved treatments for this type of cancer. Vandetanib is administered orally on a daily basis. Vandetanib’s safety and effectiveness were established in a single, randomized international study of 331 patients with late-stage medullary thyroid cancer. Patients in the study were selected to receive vandetanib or placebo.