Biologics: Diverse and Dramatic Advances

Biologics: Diverse and Dramatic Advances
Innovation.org, September 3, 2009

Research in biologics offers huge promise to patients. As scientists learn more of the molecular underpinnings of disease, our ability to treat diseases with biologics in new and innovative ways rapidly grows. A recent article in the Journal of the American Medical Association stated that biologics “represent an important and growing part of the therapeutic arsenal.”[i]

Biologics are medicines made from living material (plant, animal or microorganism) and may be derived from natural sources or engineered in a laboratory. Because they are structurally so different from most existing treatments and allow for very precise targeting, they have revolutionized treatment for many diseases. In many cases biologics are the first treatment available for a disease or they offer a significantly better way to treat a given disease. And many believe that, with more research, the near future holds many more breakthrough biologics.

Here are just a few examples of biologics that are making an enormous difference for patients:

Bevacizumab (Avastin) represents a completely new approach to attacking cancer tumors by cutting off the blood supply that feeds them. Following three decades of research in this promising area, bevacizumab was approved in 2004 to treat metastatic colorectal cancer. Since then bevacizumab has proved effective against several other forms of cancer.

Approved in 2008 to treat metastatic breast cancer, bevacizumab, in combination with paclitaxel, was shown to double progression-free survival time for women with metastatic breast cancer. The American Society for Clinical Oncology (ASCO) highlighted this a major advance of 2008.[ii]

Another recent study presented at the 2009 American Society for Clinical Oncology annual meeting found that for non-small cell lung cancer patients, bevacizumab combined with chemotherapies can slow cancer growth by up to 25%. According to the study author, "This cancer is very hard to treat. There have been some advances, but we have reached a treatment plateau and we need more agents which may help us to offer better treatment to patients…We were able to confirm that bevacizumab adds efficacy to standard chemotherapy and provides hope for patients suffering from a deadly disease."[iii]

Etanercept (Enbrel), originally approved for treatment of moderate to severe rheumatoid arthritis in 1998,[iv] has since been approved for several other autoimmune diseases, including: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis.[v]

Etanercept has contributed to great strides in treating rheumatoid arthritis. A recent study found that patients treated with combination therapy including etanercept had a 50% chance of complete clinical remission after 52 weeks of treatment, compared with 28% taking an older medicine.[vi] According to an editorial in The Lancet, these results would have been “unthinkable in the 20th century” prior to new disease-modifying biological medicines.[vii]

Trastuzumab (Herceptin) is one of the earliest and most common examples of personalized medicine. About 30% of women have a form of breast cancer that over-expresses a protein called HER2, which is not responsive to standard therapy. Trastuzumab was approved for patients with HER2 positive tumors in 1998 and further research showed in 2005, that it reduced recurrence by 52% in combination with chemotherapy.[viii] A commentary in the New England Journal of Medicine concluded that findings suggested “a dramatic and perhaps permanent perturbation of the natural history of the disease, maybe even a cure.”[ix]

These are just three examples of advances that are already benefiting patients. Based on progress like this, many experts believe that biologics are a key source for potential future advances. According to the Association of American Universities, “Biologics have enormous potential to provide breakthrough medical treatments.”[x] Researchers continue to explore the possibilities of new biologics and the promise for patients is enormous. By fostering such research we can deliver on the potential of biologics for more patients in the coming years.


References

[i]T.J. Giezen, “Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union,” Journal of the American Medical Association, 300 (October 2008): 16, 1887-1896.
[ii]American Society of Clinical Oncology, “Clinical Cancer Advances 2008: Major Research Advances in Cancer Treatment, Prevention and Screening,” Journal of Clinical Oncology, 22 December 2008.
[iii]A. Gardner, “New Treatments for Tough Cancers Show Promise,” 23 March 2007, HealthDay, http://abcnews.go.com/Health/Healthday/story?id=4507406&page=1 (Accessed 21 July 2009).
[iv]Food and Drug Administration, Approval Letter, 2 November 1998, http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/etanimm110298L.htm, (Accessed 21 July 2009).
[v]Food and Drug Administration, Drugs @ FDA, (Accessed 21 July 2009).
[vi]P. Emery, et. al., “Comparison of Methotrexate Monotherapy with a Combination of Methotrexate and Etanercept in Active, Early, Moderate to Severe Rheumatoid Arthritis (COMET): A Randomized, Double-Blind, Parallel Treatment Trial,” The Lancet, 372 (August 2008): 9636, 375-382.
[vii]J.M. Kremer, “COMET’s Path, and the New Biologicals in Rheumatoid Arthritis,” The Lancet, 372 (August 2008): 9636, 347-348.
[viii]Personalized Medicine Coalition, “The Case for Personalized Medicine,” May 2009, http://www.personalizedmedicinecoalition.org/communications/TheCaseforPersonalizedMedicine_5_5_09.pdf (Accessed 21 July 2009); Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after Adjuvant Chemotherapy in HER2-positive Breast Cancer. New England Journal of Medicine, 353 (20 October 2005):1659-72; Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-positive Breast Cancer. New England Journal of Medicine 2005; 353 (20 October 2005):1673-84.
[ix]G. Hortobagyi, “Trastuzumab in the Treatment of Breast Cancer,” New England Journal of Medicine, 353 (20 October 2005): 16, 1734-1736.
[x]R. M. Berdahl, Association of American Universities, Letter to Representative Anna Eshoo, 20 July 2009.