Just spotted this release from GSK yesterday. Never heard of Tykerb and even Google doesn't give any useful links. Is this the new trade name of one of the GS kinase inhibitors undergoing trials?
Sounds like Lapatinib.
Anyhow, note new trials being launched, PLUS agreement for a large scale early stage adjuvant trial.
Those having herceptin difficulties (heart problems, expense etc) might want to investigate where these trials will be.
Update at the 8th December San Antomnio symposium
- three new phase III trials are being initiated by January 2006, two in first-line therapy and one in refractory breast cancer
- large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005
- in mid-November, the Breast International Group and GSK agreed to collaborate on a large global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer.
JohnL
Tykerb — a targeted oral therapy with thepotential to become an essential component in the treatment of breast cancer
World-wide, 400,000 women die each year as a result of breast cancer, and its prevalence is increasing with approximately 1.5 million new cases diagnosed every year.
Tykerb, a dual-kinase inhibitor, is an oral once-daily treatment currently being developed for breast cancer and other tumors. It works by inhibiting two well-validated targets in oncology, the kinase components of ErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cell proliferation and tumor growth.
Data presented at today’s seminar, and at the recent European Cancer Conference (ECCO) in Paris, illustrate the promising efficacy and safety profile of
Tykerb. Interim results from an international phase II trial of
Tykerb as first-line therapy in 40 patients with advanced or metastatic breast cancer (with ErbB2 overexpression) showed that 33% of patients had tumor reductions, with 40% of patients experiencing clinical benefit (tumor reduction or stable disease for at least 24 weeks). A further update will be presented at the San Antonio Breast Cancer Symposium on 8th December.
Tykerb has also shown preliminary activity in the treatment of brain metastases, which represents a significant unmet medical need for breast cancer patients.
Results were recently analyzed from a 416 patient phase II/III clinical trial in the treatment of renal cancer. While the primary end-point was not met in the full population, a preliminary analysis of the sub-group of 241 patients with over-expression of EGFR demonstrated a statistically significant survival benefit for patients receiving
Tykerb. This data is expected to be presented at ASCO in 2006.
In the 3,500 patients who are part of its clinical development program,
Tykerb to date has shown a low incidence of cardiotoxicity, a condition associated with some breast cancer treatments. The most frequently reported adverse events associated with
Tykerb have been mild to moderate itching, rash, diarrhea, acne, and dry skin.
Tykerb’s clinical program has been expanded, with three new phase III trials being initiated by January 2006, two in first-line therapy and one in refractory breast cancer. A large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005. In mid-November, GSK and the Breast International Group - one of the world’s premier cancer research groups - agreed to collaborate on a large-scale global clinical trial to evaluate
Tykerb as adjuvant therapy in early-stage breast cancer.
GSK expects to file
Tykerb for US Food and Drug Administration (FDA) approval at the end of 2006 or in the first half of 2007.
Linear Mode
