FDA Approves New Drug to Treat Aggressive Breast Cancer

March 13, 2007 — -- Two years ago, cancer patient Marsha Brekke received some of the worst news that a cancer patient can hear from her doctor.

The Herceptin treatments she had been taking to keep her cancer at bay were no longer effective against the cancer that had already spread throughout her body.

"Probably the hardest thing to hear is that your chemo is no longer working," she said. "It's scary. It makes you have to face the fact that you could be dying.

"Nobody should have to deal with this when they are in their 40s."

However, the 50-year-old Minnesota woman is still alive today. And she said a new cancer drug -- experimental at the time -- was what saved her life.

The drug, called lapatinib, was approved by the U.S. Food and Drug Administration Tuesday afternoon -- clearing the way for its maker, GlaxoSmithKline, to begin marketing it under the brand name Tykerb.

The new drug is targeted to treat breast cancers that carry a special genetic marker, known as HER2.

According to the American Cancer Society, this marker usually signals a more aggressive, deadlier cancer.

And Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, writes in his blog that approximately 20 percent of the estimated 178,480 invasive breast cancers that will be diagnosed in women in the United States in 2007, will have this marker.

Herceptin, which was approved in 1998, targets these HER2 cancers. However, when this treatment fails to work, patients have traditionally had few effective options left.

That's where the new drug comes in.

"This is significant," said Dr. Cliff Hudis, chief of the Breast Cancer Medicine Service at Memorial Sloan-Kettering in New York, N.Y. "It adds a second proven HER2 targeting agent to the list of options for women with HER2-positive breast cancer."

Lillie Shockney, administrative director of the Johns Hopkins Avon Foundation Breast Center, agrees. "If a woman fails Herceptin, currently, she is stuck -- there is no replacement drug to offer her," Shockney said. "This now changes that situation."