Personalized Medicine: The Future of Health Care is Here Today

Print 26 February 2015
Peter Winter / BioWorld

Precision medicine has been capturing the headlines big time in the past couple of weeks with major initiatives being created in the U.S. and the UK. Their objective is to marshal resources to be able to accelerate the discovery and delivery of targeted therapies to patients more effectively.

The personalized approach to treatment has certainly come a very long way during the past decade. It first emerged on the health care agenda as an exciting future concept and has since evolved rapidly to the present day where it has become the mantra in any discussions relating to 21st century medicine. Its influence is accelerating as witnessed by the FDA approvals of targeted medicines, whose number has grown significantly each year. This will come as no surprise given the importance of the field with its potential to improve the quality of care and treatment outcomes.

For example, it is not uncommon for new medicines under development to now have a parallel companion diagnostic or biomarker program designed to assist in speeding development times and ultimately to help identify the appropriate patients most likely to benefit from the targeted therapies. In fact, in 2014, according analysis conducted by the Washington-based Personalized Medicine Coalition, more than 20 percent of the 41 new drugs that received the green light from the FDA’s Center for Drug Evaluation and Research (CDER) are personalized medicines.

In carrying out its assessment, the PMC said it undertook a detailed review of available data provided by the FDA on the approved products. In order to qualify as a personalized medicine the therapy’s product label needed to refer to a specific biomarker, identified by diagnostic tools, that can play a role in treatment decision making – whether or not to treat or how to treat – for an individual patient.

With this definition in hand their analysis identified nine newly approved personalized medicines from the crop of new medicines that were approved for use. These, with the reason why each was identified by PMC, included:

Astrazeneca plc’s Lynparza (olaparib), a PARP (poly ADP-ribose polymerase) inhibitor for the treatment of advanced ovarian cancer. The decision to treat with this product is affected by the BRCA biomarker status in patients.

Lynparza was approved as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The BRCA mutations, occurring in 15 percent of ovarian cancers, prevent homologous recombination, the DNA repair process that kicks in if PARP is inhibited. That means PARP inhibition can kill tumor cells without affecting normal cells. (See BioWorld Today, Dec. 22, 2014.)

The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer.

Myriad Genetics Inc., of Salt Lake City, received FDA approval for the BRCA analysis test to be used in conjunction with Lynparza.

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