Erbitux Approved for Head and Neck Cancers

By Rachael Myers Lowe, cancerpage.com

(March 1, 2006) – The FDA has approved the drug Erbitux (cetuximab) for use in head and neck cancer. The move comes after results of a large clinical trial showed the drug prolonged survival by 20 months.

It’s the first significant treatment advance since the 1950s for a cancer that strikes some 29,000 Americans every year. The drug has been approved for use in combination with radiation in localized tumors or alone in metastatic disease.

“We consider this approval an important advance,” Dr. Steven Galson, the director of the Food and Drug Administration’s Center for Drug Evaluation and Research said in the FDA press release.

“It’s very significant. It represents a new type of treatment developed on new concepts,” Dr. Kie-Kian Ang of the M.D Anderson Cancer Center in Houston told cancerpage.com.

Head and neck cancers can be particularly challenging to treat because they originate in organs important to every day functioning such as swallowing, speaking, and breathing. Surgery can have a significant affect on appearance, as well.

“When used with radiation, it (Erbitux) improves survival and reduces relapse without increasing side effects,” Dr. Ang said.

Unfortunately, not all tumors respond to Erbitux, as has been discovered in its use treating colon cancer. Dr. Ang said about 10-12% of patients will respond but he considers that a very good percentage. In addition, the physician will know within a couple of weeks whether the drug is eliciting a response.

Erbitux is one of the new targeted therapies in development against cancer. Unlike more conventional chemotherapy agents, which attack all rapidly reproducing cells, targeted therapies hone in on unique characteristics of cancer cells. As a result, the collateral damage to healthy tissue isn’t as great and side effects are greatly reduced.

Erbtiux is not without side effects. The most common are fever and chills, skin rash, fatigue/malaise, and nausea. Interestingly, the severity of the skin rash can be a good sign, showing that the drug is having eliciting a response.

Dr. Ang says Erbitux also appears to make cancers of the larynx, nasopharynx, and oropharynx more sensitive to radiation treatments and conventional chemotherapy drugs.

SOURCES:  

• FDA news release dated 3-01-06
• Cancerpage telephone interview with Dr. Kie-Kian Ang, 3-01-06
• Cancerpage news article