FDA Approves Drug Used in WVU Study

MORGANTOWN, W.Va. - The Mary Babb Randolph Cancer Center at West Virginia University is the only facility in the state to participate in a nationwide study of a new breast cancer drug, Lapatinib, recently approved by the Food and Drug Administration. The Center participated in a GlaxoSmithKline expanded access program, enabling it to offer it to patients.

GlaxoSmithKline announced March 13 that the FDA approved Lapatinib in combination with Capecitabine for treatment of advanced or metastatic breast cancer in women whose cancer progressed on prior therapy.

“This is very exciting news because this combination drug therapy is showing very promising results in breast cancer patients who’ve not done so well on prior therapy,” said Jame Abraham, MD, medical director of the Cancer Center Clinic. 

According to GSK, Lapatinib, also called Tykerb, the brand name, is the first targeted, once-daily oral treatment option for this patient population.

"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK.

The FDA approved the drug following a Phase III trial of 399 patients.  Clinical results showed a more than 40% reduction in the risk of progression of breast cancer in patients who received the combination treatment.

Fifty-five year old Patricia Dadich of Morgantown was one of nine breast cancer patients enrolled in the clinical trial at WVU’s Cancer Center.  “This drug changed my life,” said Patricia.  “During the eight years that I was on chemo, I always felt exhausted and nauseated.  Shortly after switching to the new treatment, I could actually say that I feel good when I wake up.  I feel such a difference.  It’s like a miracle hit me.”

Dadich was diagnosed with stage 4 breast cancer in 1998.  Since then, she’s had a mastectomy, a stem cell transplant and surgery to remove a brain tumor.  “I’ve been through a lot, but I received some really great news about my cancer recently” she said.  “After just two cycles of Lapatinib and Capecitabine my tumor markers dropped nearly in half, indicating that the combination drug treatment is killing more and more cancer cells.”

“We are so happy that our comprehensive cancer center can provide these kinds of options for patients like Patricia,” said Dr Abraham. 

- WVU -

For more information:
Steve Bovino, HSC News Service, (304) 293-7087
sls: 03-15-07

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