AstraZeneca cancer drug carries toxic risks: FDA

Nov 30, 2010

An experimental drug developed by AstraZeneca to treat a rare form of thyroid cancer carries "substantial toxicity" risks, the US Food and Drug Administration warned Tuesday.

Thirty-one percent of patients taking the drug, vandetanib, experienced serious side effects compared to 13 percent who did when taking a placebo.

Side effects included a potentially dangerous skin rash known as Stevens-Johnson syndrome, strokes and lung disease.

Many patients involved in studies also had to switch to lower doses, the FDA said in a report ahead of a December 2 meeting of outside experts to discuss the findings and recommend whether the drug should come to market.

Eighty percent of patients in a Phase II study that began with a 300-milligram dose of the drug "required a dose reduction or interruption."

A subsequent study that gave patients a 100-milligram dose saw 21 percent require dosage to be reduced or stopped.

"Given the substantial toxicity seen with vandetanib, should its indication be limited to patients with progressive, symptomatic medullary thyroid cancer?" the FDA asked. "Should additional doses of vandetanib be explored?"

The FDA does not have to follow the expert panel's recommendations but it often does.

expects to have a decision by January on its new drug application for vandetanib in patients with medullary thyroid cancer, a relatively rare disease that typically carries lower survival rates than other forms of .

Some 45,000 new cases are expected to be diagnosed this year in the United States.

The company says the drug works by slowing .

Vandetanib was initially set to be a treatment for but AstraZeneca withdrew its request for the drug to be put on the market for such use in 2009 after studies showed it failed to extend survival rates.

Explore further: FDA approves hard-to-abuse narcotic painkiller

add to favorites email to friend print save as pdf

Related Stories

FDA panel backs Schering-Plough cancer drug

Oct 05, 2009

(AP) -- Federal health advisers voted 6-4 on Monday that the potential benefits of a Schering-Plough drug outweigh its toxic risks as a treatment for late-stage skin cancer.

Experts veto Avastin as a breast cancer treatment

Jul 20, 2010

(AP) -- A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer, after follow-up studies failed to show benefits for patients.

FDA approves skin cancer drug

Oct 13, 2006

The U.S. Food and Drug Administration approved a new drug to treat a rare, slow-growing skin cancer.

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments : 0