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Drug Approval Signals New Era in Cancer Care

Is precision medicine gaining traction in the field of oncology?  The Food and Drug Administration’s recent approval of the cancer drug pembrolizumab offers a hint.  The agency has now approved the therapy to treat any cancer that displays specific molecular traits, marking the first time approval has been for a cancer’s genetic identity rather than its location in the body.

The decision reflects the growing influence of precision oncology, which introduces both exciting options and substantial access barriers for patients with cancer.

Precision Oncology

Cancer therapies have traditionally targeted cancer by location – lung, breast or liver, for example.  The drugs work for some patients but not for others.  In recent years, precision oncology has begun to provide a more targeted option.  Diagnostics can define a tumor’s genetic make-up, giving physicians the data they need to then prescribe a targeted therapy.  This approach can take the guesswork out of cancer care – sparing patients unnecessary cost, lost time and excess toxicity.

Precision medicine can also make valuable use of new immuno-oncology drugs, targeted therapies that harness that power of the body’s immune system to fight off cancer. (Pembrolizumab is a type of immuno-oncology drug known as a checkpoint inhibitor.)  Research shows that immuno-oncology drugs can help patients who’ve been unresponsive to previous therapies.


Patient Barriers

Despite its promise, precision oncology is not without challenges.  The advances require time-strapped physicians to educate themselves on new therapies and different diagnostic options.  And in the absence of practical guidelines on the issue, oncologists must grapple with complex questions about which patients need genetic testing, when and using which diagnostics.

Health plan coverage can present other obstacles.  Some health plans have limited coverage for precisions diagnostics.  Others may require proof that precision diagnostics and targeted therapies are “medically necessary” – a difficult burden of proof for nascent technology.  Meanwhile, patients who do receive health plan approval for precision and immuno-oncology therapies may face steep out-of-pocket costs that effectively keep the drugs out of reach.

[READ: Improving Cancer Patients’ Access to Precision Medicine]

Policymakers must take these barriers into consideration as the shift toward precision medicine becomes ever more apparent.  Just next week the National Institutes of Health launch a beta test of the Precision Medicine Initiative.  The effort will use $55 million in federal funding to establish a 1 million-person genetics database used in researching how to “prevent and treat disease based on individual differences in lifestyle, environment and genetics.”

As NIH Director Francis Collins, MD, PhD, explained, “The more we understand about individual differences, the better able we will be to effectively prevent and treat illness.”

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The Alliance for Patient Access is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.
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