New Drug for Advanced Breast Cancer Being Tested in Israel

Clinical trials being held in U.S., Europe and Israel for Tykerb; trials are joint project of FDA.

This year, a number of Israeli women suffering from advanced breast cancer will be able to receive free of charge a still-experimental new cancer medication as part of a clinical trial also being conducted in the United States and Europe.

The new medication, called Tykerb, is intended for women whose breast cancer is not responding to medication, and has metastasized, spreading to the bones, the brain, and other areas. At this phase, there is usually no way to fight the disease, and the role of the medicine is to help stop the spread of malignant cancer cells and to lessen the fierce pain they bring.

Tykerb targets two types of proteins located inside the cell membrane, which encourage the cultivation of cancerous cells, and their potential to spread metastasis from the breasts to the vital organs.

In a study published 10 days ago in the New England Journal of Medicine, Tykerb was found to be successful in doubling the life expectancy of breast cancer patients, when used in conjunction with other medications.

According to Professor Tal Zaks from the University of Pennsylvania, director of breast cancer research for Glaxo Smith Kline, the pharmaceutical company which manufacturers the medication, around 250 women in Israel suffering from breast cancer could be helped by the medication.

The clinical trial is part of the "expanded accessibility program" operated by the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medical Projects (EMEA).

Dr. Balah Kaufmann, director of the breast cancer unit at the cancer research center at Shiba hospital in Tel Aviv, succeeded in convincing the Health Ministry to include Israeli women in the research program. The medication is currently in the process of being approved in the United States and Europe, and afterwards will be approved for use in Israel.

A total of 324 women from medical centers around Israel, the United States, and Europe have taken part in the research. Half of the women were treated with chemotherapy only, and the other half were treated with chemotherapy combined with the use of Tykerb. According to Dr. Kaufmann, the research found that the combined treatment slowed the spread of malignant cancer cells for a period of around 38 weeks, while those who received chemotherapy alone showed a halt of only 19 weeks.

The expanded accessibility program is being conducted at Shiba hospital, Ichilov hospital in Tel Aviv, and Kaplan hospital in Rehovot. Hadassah hospital in Jerusalem and Rambam hospital in Haifa are also slated to take part in the program.

Pharmaceutical companies in Israel have stated that the price of Tykerb is not yet known, although they have said that the 7-8 years spent developing the drug will be a consideration in the cost.