April 2017 VOL 8, NO 4

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The RoundTable: Insight From Expert Navigators

Personalized Medicines Now Account for Nearly 1 in 4 New Drug Approvals

Daryl Pritchard, PhD, Vice President, Science Policy, Personalized Medicine Coalition 

Personalized Medicines Now Account for Nearly 1 in 4 New Drug ApprovalsIf new drug approvals are any indication, personalized medicine will be a significant part of oncology navigation in the coming years.

The FDA’s Center for Drug Evaluation and Research approved 22 new molecular entities (NMEs)—new drugs, agents, or therapeutic biologics—in 2016. Of the 22, the Personalized Medicine Coalition (PMC) classified 6 of them—including 3 of the 4 new therapeutic oncology agents—as personalized medicines, continuing a trend that PMC first documented in 2014 when it pointed out that 9 of 41 NMEs approved that year are personalized medicines. The analysis underlines that nearly 1 of every 4 drugs the agency approved from 2014 to 2016 is a personalized medicine. That ratio is a sharp increase from 2005, when personalized medicines accounted for just 5% of NME approvals.


PMC defines personalized medicine as an evolving field in which physicians use diagnostic tests to determine which medical treatments will work best for each patient. By combining the data from those tests with an individual’s medical history, circumstances, and values, healthcare providers can develop targeted treatment and prevention plans.

When evaluating NMEs, PMC categorizes personalized medicines as those therapeutic products for which the label includes reference to specific biological markers, identified by diagnostic tools, that help guide decisions and/or procedures for their use in individual patients.

Newly Approved Oncology Drugs

As noted, the FDA approved 3 personalized oncology drugs in 2016. They include:

  1. Rubraca (rucaparib) for the treatment of advanced ovarian cancer. The decision to use this product is informed by the BRCA1/2 biomarker status in patients
  2. Tecentriq (atezolizumab) for the treatment of advanced or metastatic urothelial cancer and metastatic non–small cell lung cancer. The decision to use this product is informed by programmed death-1 ligand 1 expression levels in the tumors of patients
  3. Venclexta (venetoclax) for the treatment of chronic lymphocytic leukemia. The decision to use this product is informed by the chromosome 17p deletion biomarker status in patients

Newly Approved Indications

In addition to the new drug approvals, the FDA also approved several significant new indications for previously approved personalized oncology drugs in 2016. The list of new personalized oncology drugs from 2016 should therefore be complemented with reference to newly approved indications for Imbruvica (ibrutinib), Opdivo (nivolumab), Keytruda (pembrolizumab), and Tecentriq (atezolizumab) for new molecularly defined subsets of patients. These approvals redefine the drugs’ intended populations and provide patients with effective personalized treatment options.


The FDA’s new personalized medicine approvals and expanded indications reflect the extraordinary pace of scientific innovation in the field, which the FDA has publicly encouraged.1 That progress is largely due to an extraordinary commitment to personalized medicine in the pharmaceutical and biotechnology industries.

Despite ongoing challenges in the areas of scientific discovery, diagnostic regulatory policy, reimbursement, and integration of new technologies into clinical practice, that commitment anticipates a shift away from one-size-fits-all trial-and-error medicine and toward a healthcare system that utilizes molecular information to improve outcomes and make the healthcare system more efficient. Nowhere is that trend more apparent than in oncology, where new approvals offer hope for patients who are in dire need of new treatment options.


  1. Woodcock J. FDA Continues to Lead in Precision Medicine. FDA Voice. March 2015. Accessed January 18, 2017.
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