AstraZeneca Wins U.S. FDA Approval of Thyroid-Cancer Drug

AstraZeneca Plc (AZN) won U.S. approval to sell a new treatment for advanced cases of a thyroid cancer that strikes about 2,000 Americans a year.

The Food and Drug Administration cleared vandetanib as a treatment for medullary thyroid cancer, the agency said today in a statement. The drug doesn’t have a trade name yet, the agency said.

The benefits of treating patients with few options outweigh the risk of side effects such as diarrhea, rash, nausea, hypertension and headache, an FDA advisory panel recommended in December. The agency had delayed a decision by three months to review a proposal by London-based AstraZeneca to minimize the drug’s potential risks.

“Vandetanib’s approval underscores FDA’s commitment to approving treatments for patients with rare and difficult-to- treat diseases,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

Patients with advanced, inoperable medullary thyroid tumors have about a 40 percent chance of living five years, according to AstraZeneca. The company reported in June that once-daily dosing of vandetanib helped patients live 54 percent longer than those on a placebo in a 331-person study. More than half of the patients suffered from side effects.

Seeking Products

AstraZeneca needs new products to replace about $10 billion, or 31 percent of revenue, that may be lost by 2015 as patents expire on the heartburn pill Nexium and the antipsychotic Seroquel.

Vandetanib was estimated to garner $1 billion in sales in lung cancer for the drugmaker until it failed to meet the main goal of two studies. AstraZeneca withdrew marketing applications for lung cancer in the U.S. and Europe in 2009 and has since discontinued development for the disease.

The drug is projected to bring in $82 million in sales in 2015, according to the average estimate of six analysts surveyed by Bloomberg. It also is being studied for the treatment of other tumor types.

AstraZeneca gained 21 pence, or less than 1 percent, to 2,927.5 pence at the close of trading in London.

To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; Allison Connolly in Frankfurt at aconnolly4@bloomberg.net

To contact the editors responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net; Phil Serafino at pserafino@bloomberg.net.

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