Drug-Diagnostic Co-Development in Cancer

@article{Winther2012DrugDiagnosticCI,
  title={Drug-Diagnostic Co-Development in Cancer},
  author={Henrik Winther and Jan Tr{\o}st J{\o}rgensen},
  journal={Pharmaceutical Medicine},
  year={2012},
  volume={24},
  pages={363-375}
}
Within oncology, companion diagnostics are considered to be of important value as the efficacy rates of anticancer pharmacotherapy in many cases remain low. Both the costs and the consequences of treatment failure are significant. Drug-diagnostic combinations have been known for several decades within oncology and the preselection of patients based on the differences in their biology was practiced as early as the 1970s. In relation to the development of the first companion diagnostic (for the… Expand
Companion Diagnostics in Oncology - Current Status and Future Aspects
TLDR
New ways should be developed to demonstrate the clinical utility of drug-diagnostic combinations to benefit from the increasing knowledge provided by molecular oncology, and is likely to include a number of ethical, regulatory and practical challenges. Expand
Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
TLDR
This review will give a brief introduction to some of the scientific and medical challenges related to the CDx development with specific emphasis on the regulatory requirements in different regions of the world. Expand
A Companion Diagnostic With Significant Clinical Impact in Treatment of Breast and Gastric Cancer
TLDR
HercepTest™ was the first companion diagnostic ever approved by the FDA, and more than 20 years of use has documented its clinical impact. Expand
Companion Diagnostics: From Biomarkers to Diagnostics
TLDR
CDx assays hold the promise of improving the predictability of the drug-development process and being an important tool for the clinical use of the drugs after regulatory approval. Expand
Targeted drugs and diagnostic assays: Companions in the race to combat ethnic disparity.
TLDR
It is asserted that development of drugs and CDx targeted towards molecular and centrosomal aberrations that occur more frequently in AAs could yield next generation precision medicine tools better informed and inspired by, and more finely attuned to the unique tumor biology of AAs. Expand
The HER2 CISH pharmDx™ Kit in the assessment of breast cancer patients for anti-HER2 treatment
TLDR
The US FDA has recently approved the Her2 CISH pharmDx™ Kit, which is characterized by employing a chromogenic visualization system that allows quantification of the HER2 gene and centromere 17 reference signals by relatively low-magnification brightfield microscopy. Expand
A challenging drug development process in the era of personalized medicine.
TLDR
After years of hesitation a larger number of pharmaceutical and biotech companies are now supporting the idea of a more individualized pharmacotherapy, with the key factor for success being an in-depth molecular understanding of the pathophysiology and the mechanism of the drug under development. Expand
Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges
TLDR
To fully realize the benefits of PM for healthcare systems and patients, regulatory, intellectual property, and reimbursement challenges need to be addressed in lock step with scientific advances. Expand
In Vitro Effect of Pomalidomide on Bone Marrow Mononuclear Cells From Multiple Myeloma Patients
TLDR
Pomalidomide has the potential to increase IL2 production within bone marrow mononuclear cells and consequently make changes in the immune response, which requires further studies for more clarifications. Expand
A New Look at the Corporate Capability of Personalized Medicine Development in the Pharmaceutical Industry
TLDR
A model develops a model to illustrate the corporate capability of personalized medicine development (PMD capability) in the pharmaceutical industry and finds that the critical path to contribute to PMD capability runs from NPD capability via External CoDxD capability rather than via Internal CoDXD capability. Expand
...
1
2
...

References

SHOWING 1-10 OF 49 REFERENCES
Pharmacodiagnostics and targeted therapies - a rational approach for individualizing medical anticancer therapy in breast cancer.
TLDR
Patients with a high probability to benefit from targeted therapies, such as antiestrogens, human epidermal growth factor receptor 2 inhibitors, and topoisomerase inhibitors are identified based on a biopsy from the tumor. Expand
Opportunities and challenges in the development of targeted therapies.
TLDR
It is imperative that targeted therapies are devoid of toxicities secondary to the ubiquitous nature of the target, and the authors must improve the understanding of interactions that provide specificity of signaling under physiologic conditions. Expand
The role of companion diagnostics in the development and use of mutation-targeted cancer therapies
TLDR
Development of companion diagnostic tests for this identification of patients most likely to benefit from therapies based on agents that specifically target the products of the genes that are mutated in cancer cells is proceeding. Expand
Personalized cancer therapy--the key to the future.
  • K. Sikora
  • Medicine, Biology
  • Pharmacogenomics
  • 2004
TLDR
Although the global patterns of chemotherapy use varies enormously, the overall outcomes are similar and step changes in technology may make it possible to use serumbased approaches, such as proteomics, to provide adequate information on tumor characteristics without recourse to tissue access. Expand
Targeted HER2 Treatment in Advanced Gastric Cancer
TLDR
It is expected that the encouraging results from the ToGA trial will have an immediate impact on the management of patients and that routine HER2 testing of patients with advanced gastric cancer will be initiated within a relatively short period of time. Expand
The new era of personalized medicine: 10 years later.
TLDR
There are obstacles to be overcome with regard to the implementation of personalized medicine, and besides scientific and economic issues, it will be a challenge to address other aspects, such as regulatory requirements, reimbursement, education and logistics. Expand
K-ras mutations and benefit from cetuximab in advanced colorectal cancer.
TLDR
Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab, whereas patients with a tumor bearing wild-type K-ra did benefit fromcetuxIMab. Expand
Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.
TLDR
The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression, a higher rate of objective response, a longer duration of response, and a lower rate of death at 1 year. Expand
Treatment options in metastatic renal carcinoma: an embarrassment of riches.
  • N. Vogelzang
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2006
TLDR
The first full report of a major advance in the treatment of metastatic renal cell carcinoma (RCC) is contained, showing that 45 of 53 patients treated after failure of first-line cytokine therapy had some degree of minor or major regression of disease accompanied by a median survival of 16.4 months. Expand
Randomized Phase III Clinical Trial Designs for Targeted Agents
TLDR
This article investigates the performance of several phase III clinical trial designs, both for testing the overall efficacy of a targeted agent and for testing its efficacy in a subgroup of patients with a tumor marker present. Expand
...
1
2
3
4
5
...