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Living With Cancer

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Cancer treatments are developed through a sequence of experiments, first in laboratories and animals (preclinical testing) and then in patients (clinical trials). If the clinical trial results show that the treatment helps patients, the treatment becomes part of standard treatment.

A new cancer drug must undergo rigorous testing before the US Food and Drug Administration (FDA) considers approval. First a new drug is studied in test tubes, then animals. If the drug looks promising, it's tested in people through clinical trials.

The FDA estimates that only 1 of 5 drugs makes it from preclinical research to approval for marketing source: FDA website

The FDA is responsible for reviewing the data from clinical trials and approving only safe and effective treatments.

What does that mean? All drugs have some side effects, and no drug works for everyone. Cancer drugs tend to have serious side effects (toxicities), which must be weighed against potential benefit from the treatment. A treatment that's totally effective against cancer but kills the patient doesn't help, and neither does a treatment that's safe but ineffective.

If FDA approves the drug, it can be sold for use by patients.

After a drug is approved, research continues in order to improve how patients use the drug.

Creating new cancer treatments and maximizing the benefit from existing treatments is a very complex process. However, many cancer patients learn about the drug development process and clinical trials in order to help them find additional treatment options for their disease.

Standard Treatment options

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Most cancers have standard treatment options, defined by the National Cancer Institute (NCI) as "a currently accepted and widely used treatment for a certain type of cancer, based on the results of past research." Many of these treatments are approved by the Food and Drug Administration (FDA).

Resources

National Cancer Institute (NCI) Cancer Information section
1-800-4-cancer / 1-800-422-6237

National Comprehensive Cancer Network (NCCN)

American Cancer Society (ACS) Guidelines for Patients
1-800-ACS-2345 / 1-800-227-2345

Non-Standard Treatment

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Non-standard treatment options are treatments other than the standard treatments, and can include:

Are New Cancer Drugs Better Than Existing Cancer Drugs?

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New drugs - experimental drugs being tested in clinical trials - often sound great in early news stories. Remember:

  • No cancer drug works for every patient who uses it
  • Most cancer drugs have significant side effects
  • We don't know if a new treatment will be better than the existing treatment until comparison trials are complete.

There are some new drugs - for example, Glivec - which offer a dramatic improvement to standard treatments. Unfortunately, most new drugs don't fall into that category.

Most patients are best served by standard treatments, which have been scientifically tested and have a body of research behind them. If standard treatments are either not effective or not available, a clinical trial is generally the best option.

Using Bio-Markers to Improve Treatment Selection

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Much has been written about the promise of "personalized" medicine and its potential to improve health and improve treatment outcomes. This concept is especially compelling for serious and life-threatening diseases. Much of the promise is still to be developed and proven, but there are signs of real progress. In this part of our website, we will keep you posted on treatment advances in which biomarkers or diagnostic products are useful in making treatment decisions, and also on issues or controversies as policies and technology evolve over time.

Colorectal Cancer

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In July, 2009 the FDA made important important updates to the product labels for two anti-EGFR monoclonal antibody products used to treat metastatic colorectal cancer, panitumumab (Vectibix, sold by Amgen) and cetuximab (Erbitux, sold by ImClone Systems). The label changes were made with agreement and support from the drug manufacturers and state that people with metastatic colorectal cancer who have mutations in the KRAS gene are unlikely to receive therapeutic benefit from either drug. Therefore, before receiving one of these products, a patient's tumor should be tested for KRAS status to avoid unnecessary treatment of low potential benefit. For some patients, these drugs are very effective, but unfortunately a non-mutated KRAS gene does not indicate whether or not the drugs will work for any specific patient. More work needs to be done to make this therapy truly "personalized."

You can read about the FDA's decision at this link: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm172905.htm.

For full prescribing information, including clinical trial and safety information, open this PDF for Erbitux and this PDF for Vectibix.

While official changes to the product labels of Vectibix and Erbitux were made in July 2009, many cancer advocates were given a much ealier alert to this important information a year earlier by C3: Colorectal Cancer Coalition. You can read their June, 2008 report at this link. This organization is a good source of information and perspective on new developments in the prevention, diagnosis and treatment of colorectal cancer.