Co-development of a companion diagnostic for targeted cancer therapy
| Autor: | Lin Wu, Suzanne Cheng, Walter H. Koch |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Proto-Oncogene Proteins B-raf
Oncology medicine.medical_specialty Indoles Cancer therapy Bioengineering Disease Pharmacology Neoplasms Internal medicine Humans Medicine Molecular Targeted Therapy Vemurafenib neoplasms Molecular Biology Sulfonamides business.industry Melanoma General Medicine Investigational New Drug Application medicine.disease Molecular Diagnostic Techniques Biomarker (medicine) Mutant Proteins Personalized medicine business Biotechnology medicine.drug Companion diagnostic |
| Zdroj: | New Biotechnology. 29:682-688 |
| ISSN: | 1871-6784 |
| DOI: | 10.1016/j.nbt.2012.02.002 |
| Popis: | Oncology drug development is a long and costly process associated with a success rate of 5-10%. The parallel development of companion diagnostic tests that will identify patients most likely to receive benefit has the potential to increase the success rate for oncology drugs and decrease development time and associated costs. Metastatic melanoma is a challenging disease that has been associated with poor survival. Identification of a mutated BRAF kinase gene in many cases of melanoma provided a promising therapeutic target. Here we describe the successful co-development of vemurafenib, a first-in-class selective inhibitor of oncogenic BRAF kinase, and its companion diagnostic, the cobas(®) 4800 BRAF V600 Mutation Test. Key success factors in the development process included early identification of the BRAF V600E biomarker, early development of the diagnostic test, and early and close collaboration between the pharmaceutical and diagnostic development teams. This focused and integrated process resulted in the first personalized medicine for the treatment of metastatic melanoma less than five years after the Investigational New Drug Application, a remarkably short time. |
| Databáze: | OpenAIRE |
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