Ryan (the CEO and founder of DNA Direct ) and I just returned from an FDA meeting where members of the Clinical Pharmacology Subcommittee, a group composed of doctors and researchers, made an important decision about the breast cancer drug tamoxifen. As Lisa Lee described last week, the purpose of this meeting was to decide whether to recommend changing the tamoxifen package insert, also known as the drug label, to include information about how the 2D6 gene is a predictor of response to tamoxifen.
Clearly the decision of the Subcommittee is a historic moment, both for the emerging field of pharmacogenetics (or how genes influence a patient’s response to drugs) and, most importantly, for the breast cancer community. After all, hundreds of thousands of women are on the drug tamoxifen, and more women are put on the drug every day. The fact that some of them may not be receiving full benefit from tamoxifen because of their genes — therefore increasing their risk of cancer recurrence — could not be more important for breast cancer patients to know about.
So, what did the Subcommittee recommend? After hearing a series of presentations (including one by Ryan), the Subcommittee addressed the following question:
Does the clinical evidence demonstrate that postmenopausal women with ER-positive breast cancer who are CYP2D6 poor metabolizer are at increased risk for breast cancer recurrence?
The Subcommittee unanimously answered yes to this question. They then addressed the next question:
Should the tamoxifen label include information about increased risk for breast cancer recurrence in CYP2D6 poor metabolizers prescribed tamoxifen?
Again they unanimously answered yes.
So, what does this mean? The FDA will now take the recommendation of the Subcommittee and move toward re-labeling tamoxifen to include this new information about how a genetic test for 2D6 can predict response to tamoxifen. Based on recent history, we know this process will take time, maybe even a year or more.
The real question to ask is: What does this mean for breast cancer patients on or considering taking tamoxifen? After all, these are the people for whom this new information matters the most.
Get Educated: Information is power. If you are a breast cancer patient on or considering tamoxifen, or you know someone who is, then you need to know everything you can about how a genetic test can provide essential information about whether tamoxifen will be an effective therapy. The good news is that we at DNA Direct have done the research for you. You can find all the important information about this genetic test for tamoxifen on our website, called Genes & Drugs.
Talk to an Expert: Understanding medical information can be a team effort. If you have questions about the genetic test for tamoxifen, you should consider talking to your personal physician or a genetic counselor (you can find one near you at the NSGC website ). You can also talk to DNA Direct’s professional staff of genetic experts. We’re here to help answer your questions. Call us at 1-877-646-0222 or email firstname.lastname@example.org
Consider Testing: If you’re interested in getting the genetic test for tamoxifen, you can work with your physician or order the test directly from DNA Direct. On the Genes & Drugs website, you can learn more about whether testing is appropriate for you, order a test, get a cheek-swab test kit in the mail, and receive a personalized report explaining how your genes will affect your response to tamoxifen. We are the only online company that makes this service available to patients. Learn more here.