Remember the Jetsons? High rise apartments floating in the clouds, personal spaceships, and robotic maids. Do we have any of these things? Nope, nope, and…well, maybe, if you wait until about 2015, have plenty of disposable income, and feel comfortable telling something that looks like Robocop that it missed a spot.

But while you’re bemoaning your inability to purchase a jet pack, some pieces of the future are here, now—and have been for some time. Take “personalized medicine,” for example. It doesn’t mean the development of “tailored medicine” for an individual patient, but something much more practical: the use of medical information for better patient diagnosis and more targeted, effective treatment.

For example: Targeted help for 25% of breast cancer patients.

Herceptin is the best-known example. Approved for the treatment of breast cancer in 1998, it’s indicated for patients in whom the HER2 receptor protein is overexpressed, which occurs in about 25% of all primary breast cancers. This sort of genetic variation is often referred to as a biomarker.  A clear, compelling (even for non-scientists) MOA video can be found on the website.

These new insights are currently most used in oncology, since cancer has a strong genetic component and there are great variations in response to the same therapy. Take Iressa, used in the treatment of non-small lung cancer. It targets and blocks the activity of EGFR-TK, an enzyme involved in cancer cell proliferation and survival. About 10-20% of non-small cell lung cancers in Europe and about 40% in Asia are due to tumors with an EGFR-TK mutation, which are especially sensitive to treatment with Iressa.

Is this another ode to the end of the blockbuster era?

Not really. For drugs like abacavir, used in the treatment of HIV, it could mean more confidence among prescribing physicians. Some patients have severe adverse reactions to abacavir, but it was found that they could be identified by a genetic variant.

As more and more drugs are developed with companion diagnostic tests, companies can spend less on drugs that have less chance of being approved. They can also take another look at subgroups from clinical trials to identify the patient populations most likely to respond to a drug. Rather than limiting possibilities, the use of biomarkers allows drugs to be marketed to appropriate patients. Companion diagnostics can lead to improved clinical trial data, greater chance of FDA approval, and even allow so-called “niche” drugs to become first-line therapies for the right patients. The FDA now recognizes 32 distinct biomarkers, and more guidance is forthcoming.

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