Rx Minute: Biopharmaceutical companies embracing personalized medicine

Biopharmaceutical companies embracing personalized medicine

A new report from the Tufts Center for the Study of Drug Development finds that biopharmaceutical companies are committed to researching and developing personalized medicines. The data show, for the first time, the extent to which companies are embracing this new research: of the companies surveyed, 94% said they are investing in personalized medicine (PM) research. In many instances, companies’ investment is translating into the development of therapies that have a companion diagnostic. Companies report that within their development pipelines, 12%-50% of compounds are personalized medicines.

Personalized medicine is changing the way biopharmaceutical companies research new medicines. One hundred percent of companies surveyed said that they are using biomarkers in the discovery stage of research to help learn more about a compound. Biomarkers are molecular, biological or physical characteristics that can help identify risk for disease, make a diagnosis, or guide treatment, and they are a key component of personalized medicine.

Many of the most promising personalized medicines are still in the early stages of research. Among treatments in preclinical development nearly 60% rely on biomarker data. In early clinical research that proportion is close to 50% and in late clinical development about 30% use biomarkers.

The authors conclude, “The industry as a whole is committed to pushing strongly ahead,” and “early indications show that development of personalized medicines is commanding more resources and fomenting more corresponding organization change than is generally appreciated outside the industry.”

Major advances in cancer medicines in 2010

A new report from the American Society of Clinical Oncology (ASCO) highlighted 53 of the most significant findings of 2010, including 12 that the report’s editors consider “major advances”. Among the 12 major advances, 8 related to new medicines, better ways to use existing medicines, or newly discovered benefits of approved medicines.

Examples of the major advances included in the report:

  • New personalized medicine shows high response in lung cancer patients: A phase I study found that more than 90% of lung cancer patients with a specific ALK gene mutation responded to treatment with a potential new medicine, crizotinib.
  • A first for improving advanced melanoma survival: The first-ever phase III randomized trial to show improved survival for patients with advanced melanoma. The experimental biologic, ipilimumab, resulted in patients living 34% longer after two years.
  • Improving progression-free survival in hard-to-treat ovarian cancer: Studies found that the anti-angiogenesis drug bevacizumab to the standard chemotherapy regimen, followed by longer-term treatment with bevacizumab, significantly extended life for women with ovarian cancer, which is generally very difficult to treat.

ASCO President, George W. Sledge Jr., MD, wrote that “Progress against cancer is being made every day—measurable both in our improved understanding of the disease and in our ability to treat it.” However, “sustained national investment in cancer research is needed,” to continue to advance treatment options.

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