Thread: US approves Tykerb for advanced breast cancer

US approves Tykerb for advanced breast cancer
Tue Mar 13, 7:04 PM ET


WASHINGTON (AFP) - US drug regulators approved Tuesday the targeted anti-cancer treatment Tykerb (lapatinib) for use together with another drug, Xeloda (capectabine) in certain advanced breast cancers.

The Food and Drug Administration approved the drug combination for women with advanced metastatic breast cancer that is HER2 positive, saying tests showed it slowed the advance of the cancer.

"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," said Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "New targeted therapies such as Tykerb are helping expand options for patients," he said.

Some 180,000 new cases of breast cancer are diagnosed each year, and annually 8,000-10,000 women died from metastatic HER2 breast cancer, the FDA said.

The approval came after a clinical trial on 400 women suffering from advanced HER2 positive breast cancer. The FDA said the study showed a "statistically significant improvement" in the time to tumor progression in the group taking the combination of the two drugs.

But they offered no data on survivors after the treatment, saying it was too early to make any determinations.

The FDA warned that Tykerb, produced by pharmaceutical maker GlaxoSmithKline, can produce side effects including diarrhea, nausea, vomiting and rash, and numbness, tingling, redness, and swelling in the hands and feet.

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