Tykerb new drug in pill form like Herceptin

[CLTann]

Just heard news of Glaxo's new drug being applied for approval by FDA. Anyone has more info on this?

Ann

[eric]

This might help... http://investing.reuters.co.uk/inves...ALTH-GLAXO.xmlLONDON (Reuters) - GlaxoSmithKline expects to have four key cancer drugs in final-stage clinical trials next year, it said on Wednesday.

Europe's biggest drug maker said the four drugs -- Tykerb, formerly known as lapatinib, eltrombopag, casopitant and pazopanib -- all held promise for fighting tumours or helping patients overcome the side-effects of chemotherapy.

Until now, oncology has been a small area for Glaxo but the group believes new products will make it a major player in the fast-growing world of cancer medicine.

It will give further details on compounds in development to analysts and investors at an Oncology and Supportive Care seminar in New York at 2:30 p.m.

Cancer currently accounts for a modest 1 billion pounds or 5 percent of Glaxo's group sales, mostly due to anti-nausea drug Zofran, which is given to chemotherapy patients.

New drugs in development promise to change that, although it will not happen overnight, and industry analysts believe many of the products in development will not have a significant impact on profits until after 2010.

One of the biggest new drug hopes is eltrombopag, a treatment for low levels of platelets in the blood, which Glaxo said had produced good results in Phase II clinical tests in patients with idiopathic thrombocytopaenia purpura (ITP). Glaxo expects to file the drug for regulatory approval by the end of 2006 or in 2007.

Analysts at Merrill Lynch believe eltrombopag could eventually become a $2.8 billion-a-year seller, provided it is shown to work in patients undergoing chemotherapy.

Glaxo (GSK.L: Quote, Profile, Research) also has high hopes for Tykerb, a dual-action oral cancer therapy in Phase III studies, which is being developed initially for breast cancer.

New data showed the drug's potential in shrinking tumours in patients with advanced breast cancer and fighting brain metastases, although the product had mixed results in kidney cancer.

Glaxo intends to file for U.S. approval of Tykerb at the end of 2006 or in the first half of 2007.

Shares in Glaxo, which fell 5 percent earlier this month on fears tougher U.S. regulations would hit sales of its top-selling asthma drug Advair, pared earlier losses to stand 1.1 percent down on the day at 14.33 pounds by 1:25 p.m. in a weaker London market.

[Tom]

Hi Eric. Here is a little more detail on Tykerb's progress from the Glaxo-Smith Kline stockholder's confernece call early this morning. I'll provide the link and the text that deals with Tykerb. I thought their new name was clever. Tyk for tyrosine kinase, and erb for the erb1 and erb2 receptors it inhibits. I hope it is as clever at shutting down the malignant cells.

http://www.gsk.com/ControllerServlet...402&newsid=697#






- 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.