The Cancer Biomarker Problem


In 2008, Dr. Charles Sawyers, currently the president of American Association for Cancer Research, wrote an article for the journal Nature entitled: ‘The Cancer Biomarker Problem.’ This excellent paper clearly explains what cancer biomarkers are, outlines the different categories of biomarkers, and emphasizes how important biomarkers are in the field of targeted therapies. Predictive biomarkers are indispensable tools that should direct the rational use of targeted drugs in cancer patients. There are additional types of biomarkers, including some that could help evaluate the course of cancer progression or help determine the effective dose of an investigational drug. But this post focuses on predictive biomarkers. Continue reading…


Afatinib is FDA-Approved: What It Means For NSCLC Patients


On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.

EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…


Scientists Refine and Develop New Strategies to Target Bone Metastases


Metastasis is responsible for most cancer deaths, but the organs to which specific types of cancers migrate differ. Prostate cancers tend to metastasize to bone tissue, causing bone-related complications. The symptoms of bone metastases can be very painful and disruptive. Fortunately, some patients can benefit from therapies developed specifically to treat these complications. Continue reading…


The Gap in Medical Testing

An alarming number of diagnostic medical tests have never been tested for safety and accuracy. That’s because the federal government has a two-tier system for regulating such tests. If a diagnostic test is made by a traditional device manufacturer, the Food and Drug Administration reviews its safety and effectiveness before approving it for marketing. However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review.”


The Gap in Medical Testing

An alarming number of diagnostic medical tests have never been tested for safety and accuracy. That’s because the federal government has a two-tier system for regulating such tests. If a diagnostic test is made by a traditional device manufacturer, the Food and Drug Administration reviews its safety and effectiveness before approving it for marketing. However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review.”


The Gap in Medical Testing

An alarming number of diagnostic medical tests have never been tested for safety and accuracy. That’s because the federal government has a two-tier system for regulating such tests. If a diagnostic test is made by a traditional device manufacturer, the Food and Drug Administration reviews its safety and effectiveness before approving it for marketing. However, if a test is developed by a clinical laboratory for use at its own facilities, it can be sold without a premarket review.”


Developing Standards for Breakthrough Therapy Designation in Oncology

“In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential “breakthrough” drugs or treatments that show dramatic responses in early phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a “Breakthrough Therapy”, the FDA and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development.”


Developing Standards for Breakthrough Therapy Designation in Oncology

“In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential “breakthrough” drugs or treatments that show dramatic responses in early phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a “Breakthrough Therapy”, the FDA and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development.”


Developing Standards for Breakthrough Therapy Designation in Oncology

“In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential “breakthrough” drugs or treatments that show dramatic responses in early phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a “Breakthrough Therapy”, the FDA and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development.”