New Breast Cancer Drug TYKERB Awaits FDA Approval
GlaxoSmithKline plc, one of the world's leading research- based pharmaceutical and healthcare company, announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval to market Tykerb, its experimental breast cancer drug.
Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK said, “This filing is the result of many years of tremendous research and development work by the scientists at GSK. It is truly an outstanding milestone, especially for the many thousands of women who are facing the devastating effects of advanced breast cancer.”
Tykerb (lapatinib ditosylate), in combination with Xeloda (capecitabine) is competent for treating advanced or metastatic HER2 (ErbB2) positive breast cancer in women.
Researchers at GSK claim that the new drug, TYKERB, when used in combination with Xeloda of Roche Pharmaceuticals, shows outstanding results for HER2 gene mutation in cases where earlier Herceptin along with other cancer tharapies have failed to show results.
In a study conducted over 324 HER2-positive women whose breast cancer had spread despite treatment with Herceptin and other cancer therapies, the combination of TYKERB and Xeloda versus Xeloda alone nearly doubled the time to progression.
In the pivotal trial, the median time to progression nearly doubled to 36.7 weeks in combination of TYKERB and Xeloda versus 19.1 weeks during Xeloda alone.
When administered orally, Tykerb, restrains the tyrosine kinase components of EGFR (ErbB1) and HER2 receptors which are believed to play a role in promoting cancer.
By early next year, Europe’s biggest drug maker plans to launch a trio medication to fight cancer, Tykerb being one of them. The other two include Cervarix, a cervical cancer vaccine and platelet-booster eltrombopag.
The drug is also under further research and deveopment and is being tested for its effectiveness at treating other forms of solid tumors.
After being approved in the U.S., GlaxoSmithKline also plans to file for a European approval also.
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Is Tykerb better than Herceptin?
Maybe, for these reasons.
Cells are the most basic structure of the body. Cells make up tissues, and tissues make up organs, such as the lungs or liver. Each cell is surrounded by a membrane, a thin layer that separates the outside of the cell from the inside.
For a cell to perform necessary functions for the body and respond to its surroundings, it needs to communicate with other cells in the body. Communication occurs through chemical messages in a process called signal transduction. The purpose of these signals is to tell the cell what to do, such as when to grow, divide into two new cells, and die.
Targeted cancer therapies use drugs that block the growth and spread of cancer by interfering with specific molecules involved in carcinogenesis (the process by which normal cells become cancer cells) and tumor growth. By focusing on molecular and cellular changes that are specific to cancer, targeted cancer therapies may be more effective than current treatments and less harmful to normal cells.
However, the monoclonal antibodies like Herceptin and Erbitux are "large" molecules. These very large molecules don't have a convenient way of getting access to the large majority of cells. Plus, there is multicellular resistance, the drugs affecting only the cells on the outside may not kill these cells if they are in contact with cells on the inside, which are protected from the drug. The cells may pass small molecules back and forth.
Exciting results have come from studies of multitargeted tyrosine kinase inhibitors, "small" molecules that act on multiple receptors in the cancerous cells, like Tyberb and Sutent. Targeted "small-molecule" therapies ruled at the recent annual ASCO meeting of oncologists. The trend is away from the monoclonals to the small molecules, a trend in which a new predictive test may be able to hasten.
The EGRFx (TM) assay is able to test molecularly-targeted anti-cancer drug therapies like Iressa, Tarceva, Tykerb, Sutent and possibly Nexavar, because of being small molecules. The EGFRx (TM) assay relies upon a technique known as Whole Cell Profiling, in which living tumor cells are removed from an individual cancer patient and exposed in the laboratory to the new drugs.
Basically, Whole Cell Profiling measures the response of the tumor cells to drug exposure. Following this exposure, it measures both cell metabolism and cell morphology. The effect of drugs on the whole cell, resulting in a cellular response to the drug, measures the interaction of the entire genome.
A variety of metabolic and apoptotic measurements are then used to determine if a specific drug was successful at killing the patient's cancer cells. The whole cell profiling method differs from other tests in that it assesses the activity of a drug upon combined effect of all cellular processes, using several metabolic (cell metabolism) and morphologic (structure) endpoints, at the cell "population" level (rather than at the "single cell" level).
Other tests, such as those which identify DNA or RNA sequences or expression of individual proteins often examine only one component of a much larger, interactive process. Whole Cell Profiling measures genes before and after drug exposure. Gene Expression Profiles measures the gene expression only in the "resting" state, prior to drug exposure.