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Drugs, Vaccines and Therapeutics
by ruth on March 16, 2007

- 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.
Read the full report.
Trackback: http://publish.creative-weblogging.com/publish/mt-tb.pl/58310
Mr Wong
Vote for TYKERB®: GlaxoSmithKline's Breast Cancer Drug, Approved by the FDA:
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Rating: 6.25 out of 4 vote(s) cast.
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Response from:
Drug Addiction
(05/17/07 8:24am)
AT last women can have one more Ace in their sleeve while fighting cancer. This problem is becoming a really headache.
Response from:
norvasc generic
(05/29/07 11:10am)
Well… it has been approved, yes, but remember that other drugs had the same experience and they were drawn off because of the many problems they caused. So, let us be patience and see what it is capable of.
Response from:
methadone detox
(10/16/07 7:51am)
My sister has breast cancer that has recently come back in her lymph nodes. She is going to start the drug Tykerb as soon as we find someone who handles it, since I understand this is fairly a new cancer treatment drug. Can you supply me with further information about this medication?
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