New cancer drug effective; for a price

Diagnosed with breast cancer in 2001, Pine Islander Imelda Yerkes has been taking the FDA newly approved Tykerb for the past five months as a part of a clinical trial but may be denied access to it now because of cost.

The drug, which is manufactured by GlaxoSmithKline, received approval from the U.S. Food and Drug Administration on March 14. It an oral medication that is geared toward treating breast cancer that has spread to other areas and involves the HER2/neu gene. The gene is involved in about a quarter of all breast cancer cases, according to Florida Cancer Specialists founder and president Dr. William Harwin.

An estimated 212,920 women and 1,720 men were diagnosed with breast cancer in 2006, according to the American Cancer Society. More than 40,000 women and 460 men died of the disease.

Tykerb, which received approval when used in conjunction with the oral chemotherapy drug Xeloda, slows progression of the disease, according to nationwide clinical studies. A month's prescription costs $2,900 or roughly $25 a pill. Patients take four pills a day.

"This approval reflects more than 16 years of research, including more than 60 clinical trials and investigator initiated collaborative research studies," said Dr. Paolo Paoletti, senior vice president of the Oncology Medicine Development Center at GlaxoSmithKline.

Yerkes, 43, discovered the lump in her breast, but said she was in denial and waited to have it checked out until it had spread to her lymph nodes. The cancer has continued to spread and is now in her liver.

"I waited too long and it didn't go away," Yerkes said.

Harwin's practice, which has offices from Bradenton to Naples, participated in Tykerb clinical trials during a two year period of time and administered Yerkes' doses.

"We saw some excellent results," Harwin said. "It has definitely helped people."

Another advantage of Tykerb is that it crosses the blood-brain barrier, unlike other drugs, and may benefit patients that have had breast cancer spread to their brains, according to Harwin.

He said about two-thirds of all the participants in the trial experienced good results while taking the drug. Some of the side effects include diarrhea, nausea and a mild skin rash. Yerkes experienced the rash, which she compared to teenage acne.

"We now have a new drug that offers promise and hope to women who have a more aggressive form of breast cancer where until very recently, we had little to offer," said Dr.Len Lichtenfield, deputy chief medical officer for the American Cancer Society.

Following approval, Harwin said the first prescription he wrote for the drug was to Yerkes.

The drug, once prescribed, has to be ordered through a specialty pharmacy.

GlaxoSmithKline has set up a toll free informational line at 1-866-489-5372. n