FDA Approves Vandetanib For Medullary Thyroid Cancer

Editor's Choice
Main Category: Cancer / Oncology
Also Included In: Ear, Nose and Throat;  Regulatory Affairs / Drug Approvals
Article Date: 07 Apr 2011 - 11:00 PDT


Vandetanib has been approved by the FDA (Food and Drug Administration) for the treatment of late-stage medullary thyroid cancer in adults who cannot have surgery, and whose disease is progressing and causing symptoms.

Thyroid cancer is cancer of the thyroid gland, located in the front of the neck. The thyroid gland produces hormones which control our body's metabolism, heart rate, body temperature, weight and blood pressure. Although not common, thyroid cancer incidence is growing.

Medullary thyroid cancer makes up approximately 3% of all thyroid cancers. The cancer starts in the C cells of the thyroid. Cancers that begin in the C cells make extremely high levels of calcitonin. This type of thyroid cancer develops slowly.

In 2010, there were approximately 44,600 new thyroid cancer diagnoses in the USA, and 1,690 deaths, according to the National Cancer Institute. Between 1,300 and 2,200 people each year in the US are diagnosed with medullary thyroid cancer.

Medullary thyroid cancer symptoms may include swallowing difficulties, enlargement of the thyroid gland, neck swelling, a lump on the thyroid, coughing, and alterations in the patient's voice.

Vandetanib targets the cancer's ability to expand and grow. There are no available FDA-approved treatments for medullary thyroid cancer.

The FDA informs that it examined the results of a single, randomized international study involving 331 individuals with late-stage (metastatic) medullary thyroid cancer. They were randomly selected to receive either vandetanib or a placebo (dummy drug).

The study's primary endpoint was progression-free survival - in other words, its aim was to determine how long the patient survived without the cancer progressing.

The study showed that for those on vandetanib, progression-free survival averaged 22.6 months, compared to 16.4 months for those on the placebo. The FDA says it is too early to determine whether the vandetanib patients will live longer than the placebo ones.

Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said:

"Vandetanib's approval underscores FDA's commitment to approving treatments for patients with rare and difficult to treat diseases."

The following side effects may occur when taking vandetanib: nausea, hypertension (high blood pressure), headache, less appetite, abdominal pain, rash, and diarrhea. Vandetanib may also cause irregular heartbeat, which in some cases may be life-threatening.

AstraZeneca Pharmaceuticals LP, Wilmington, Del., USA, markets vandetanib. There is no established trade name for Vandetanib yet.

Howard Hutchinson, Chief Medical Officer, AstraZeneca, said:

"Vandetanib is the only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer and is the first treatment that AstraZeneca has developed and brought to market under orphan drug designation in the US."

Source: FDA, AstraZeneca.

Written by Christian Nordqvist


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations