FDA Approves New Breast Cancer Drug

Tykerb May Be Second-Line Treatment for Some Advanced Breast Cancers

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

March 13, 2007 -- The FDA today approved a new breast cancer drug called Tykerb for some advanced breast cancers.

The FDA approved Tykerb for use in combination with another cancer drug, Xeloda, to treat certain patients with advanced breast cancer or breast cancer that has spread (metastatic breast cancer).

Specifically, the Tykerb-Xeloda combination is approved only for patients with advanced or metastatic breast cancer whose tumors contain too much of a protein called HER2 and who have already tried other treatments, including chemotherapy and the drug Herceptin, which targets HER2-positive breast cancer.

The FDA's Steven Galson, MD, MPH, commented on Tykerb's approval. Galson directs the FDA's Center for Drug Evaluation and Research.

"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," Galson says in an FDA news release.

"New targeted therapies such as Tykerb are helping expand options for patients," Galson says.

Patients would take one Tykerb pill daily. Tykerb will be available in the U.S. within two weeks, says GlaxoSmithKline, which makes Tykerb. GlaxoSmithKline is a WebMD sponsor.

The American Cancer Society's deputy chief medical officer, Len Lichtenfeld, MD, commented on Tykerb's approval in a statement emailed to WebMD.

"The approval of Tykerb is a significant step forward because it once again demonstrates the promise of targeted therapies," Lichtenfeld says.

However, Lichtenfeld says Tykerb's approval generally won't change the way most breast cancer patients are treated.

Drug's Approval

The FDA approved Tykerb based on a trial of about 400 patients with advanced or metastatic breast cancer who had HER-positive tumors and who had already taken Herceptin and other cancer therapies.

In the trial, half of the patients took Tykerb with Xeloda. The rest only took Xeloda.

On average, cancer progressed in about 27 weeks in patients taking Tykerb with Xeloda, compared with about 18 weeks for those only taking Xeloda. The tumor response rate was also higher with Tykerb and Xeloda than with Xeloda alone.

Survival data from the trial are "not yet mature," says the FDA, meaning that it's too early to know whether survival was greater with Tykerb plus Xeloda than with Xeloda alone.

GlaxoSmithKline is studying Tykerb in other breast cancer patients.

Adverse Events

In the clinical trial, adverse effects were similar for both groups.

The most commonly reported Tykerb-related side effects included diarrhea, nausea, vomiting, rash, and hand-foot syndrome, which may include numbness, tingling, redness, swelling, and discomfort in hands and feet.

Generally reversible decreases in heart function (that can lead to shortness of breath) have also been reported in a small percentage of patients. The FDA advises patients to talk to their doctors about potential side effects, drug interactions, and other medical conditions including heart and liver problems.

Uses Limited

"We need to remember that [Tykerb] was tested only in women with advanced and progressing breast cancer where other treatments -- including chemotherapy and [Herceptin] -- had failed," Lichtenfeld says.

"So these were the types of situations where any response was welcome news, even if it didn't prolong survival," he says.

Lichtenfeld predicts that Tykerb may one day be tested against Herceptin in a head-to-head trial.

"There may even come a time when both drugs will be used together to find out if the combination is more effective than either drug alone," Lichtenfeld says.

"But for now, [Tykerb] is going to be used to treat women with breast cancer where [Herceptin] is no longer effective, or where a woman cannot tolerate [Herceptin]."

SOURCES: News release, FDA. News release, GlaxoSmithKline. Statement from Len Lichtenfeld, MD, deputy chief medical officer, American Cancer Society. WebMD Health News: "Tykerb Helps Late-Stage Breast Cancer."

© 2007 WebMD Inc. All rights reserved.


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