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Q: I heard that the FDA might let women try new drugs for breast cancer earlier. What can you tell me about this?
A: Yes, the FDA is planning to try an innovative approach in testing new drugs for breast cancer in the hopes of giving more women with aggressive, early-stage cancers the chance to try promising drugs while they have the best chance at a cure.
In June 2012, the FDA issued a new guidance document that would allow drug companies to test their promising medications for a few months on women with highly aggressive breast cancers before they have surgery, with the hope this therapy would be a cure.
Traditionally, by the time experimental drugs are tried on women with earlier-stage disease, they have been tested in thousands of women with more advanced disease, for whom the risk of trying the drug is balanced with its potential for prolonging their lives.
The new FDA treatment guidance document will apply to women with an especially deadly form of the disease called “triple-negative” breast cancers.
Most breast tumors are called estrogen-receptor positive, because they are fueled by the hormone estrogen. Other breast tumors are HER2-positive, because a protein called HER2 is involved. A third type is driven by the hormone progesterone. These types of breast cancer have good treatments, but “triple-negative” tumors tend to grow and spread more quickly, occurring more often in younger or black women.
The proposed early treatment approach is termed “neoadjuvant” therapy, in which women are treated with either approved chemotherapy or approved chemotherapy plus an experimental drug for a few months prior to surgery. If women in the experimental drug group achieve a substantial improvement compared to the other group, the new drug would be given a provisional type of FDA approval called “accelerated approval.”
The researchers would then continue to follow women receiving the drug for several years to see if the treatment is safe and if their cancers come back. If treated women continue to be disease-free without serious side effects, the drug could then get full FDA approval.
This novel treatment approach could potentially speed access to new breast cancer drugs. Breast cancer is the second-leading cause of death in women, exceeded only by lung cancer, according to the American Cancer Society.
Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.