TYKERB®: GlaxoSmithKline's Breast Cancer Drug, Approved by the FDA

Filed in archive Drugs, Vaccines and Therapeutics on March 15, 2007

The first targeted, once-daily oral treatment option for the following patient population:

• patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab

...GlaxoSmithKline's breast cancer drug TYKERB® (lapatinib) has recently been approved by the US FDA in combination with Xeloda® (capecitabine) for the treatment of advanced metastatic breast cancer in the specified patient population.

The said FDA approval represents more than 16 years of research, including more than 60 clinical trials and investigator-initiated collaborative research studies.

According to Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK:

"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.

The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."

Granted priority review by the FDA in November 2006, TYKERB® is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer - it inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth.

Within two weeks of this approval, TYKERB® will be available in the United States.

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