A notable year for personalized medicine

Personalized medicine has long been considered the probable next step in the evolution of pharmaceutical development. Knowledge of the  human genome can and has been used to optimize the treatment of disease and to provide specific cures for specific patients. The coupling of pharmaceuticals with corresponding diagnostics makes sense from a treatment standpoint and also provides a business opportunity. One Pharma highlight of 2011 was that two significant personalized medicine products were approved. XALKORI® (crizotimib) was approved for use in ALK (anaplastic lymphoma positive kinase) and ZELBORAF® (vemurafenib),  for melanoma . Both drugs  were developed for diseases attributable to readily detectable genetic mutations.  Both drugs were approved with corresponding diagnostic kits

XALKORI, supplied by Pfizer, is a kinase inhibitor. In approximately 5% of NSCLSC patients, chromosomal rearrangement leads to formation of the EML-ALK fusion gene. The increased kinase activity results in carcinogenesis. XALKORI has demonstrated excellent remission rates in clinical studies of patients with positive ALK. The Vysis ALK Break Apart FISH Probe Kit  is used to identify suitable candidates for XALKORI treatment by detecting the mutation in tumor cells.

ZELBORAF  is a BRAF Kinase Inhibitor. A mutation of the BRAF gene can be found in over 50% of  patients with melanoma. ZELBORAF was co-developed by Roche and Plexxikon. It too is accompanied by a diagnostic kit; the cobas 400 BRAF V600 Mutation Test. ZELBORAF has been demonstrated to be a useful ameliorative treatment for late stage melanoma patients.

Both approvals are encouraging and significant advances in personal medicine. Although not without its critics, mostly for issues of patient privacy, personalized medicine holds the promise of improved health care in the future – and this year could be a noteworthy first step  in that direction.