The FDA Streamlines Approval Process and Improves Cancer Drug Development

  • Posted on December 17, 2014 by Pharma Models Blogging Team in Oncology

Scientists have spent the last century developing better cancer treatments and uncovering causes of tumor growth in order to save lives. However, today the U.S.-based scientific community is able to do little without the approval of the Food and Drug Administration (FDA). Luckily, the FDA has recently moved forward in enhancing cancer treatments and research protocols.

According to the FDA Voice publication, the organization approved an innovative medication called Zykadia (certinib) in May for treating late-stage, non-small cell lung cancer. This was one of four therapies that were approved for treating lung cancer since 2011. More importantly, these treatments are targeted at grasping the condition at hand and its causes.

Over the last ten years, scientific evidence has increased in quality to the point that lung cancer can be classified by using patients’ molecular profiles and treating it by subtype. We can now identify oncogenes that cause a cell or tissue to become malignant and scientists have begun targeting these oncogenes and halting tumorigenesis.

The newly approved drug is able to help treat a small population of lung cancer patients that previously had little hope of recovery. Zykadia blocked a protein that led to the development of tumor cells – in a clinical trial of 163 patients positive for this protein, about half of the participants had their tumors decrease in size.

The FDA approval process shows how important the organization is to the overall collaboration within industry, stakeholders, and health advocacy groups. Additionally, fast approval turnaround from the FDA shows their support of early patient access to new and innovative therapies. For Zykadia, it took the FDA less than four years from the date of initial study to approve the drug.

The organization plans to further improve cancer research protocols by incorporating the master protocol in which several drugs and biomarkers can be tested in one clinical trial. The FDA is also dedicated to creating new therapies for childhood cancers.

FDA Commissioner Dr. Margaret Hamburg reported that she spoke with Nancy Goodman, founder of the patient advocacy group Kids and Cancer. Hamburg discussed the latest development in pediatric cancer with this advocacy organization. Pediatric cancer research has often had major obstacles between our need to develop treatments for children against the importance of avoiding drugs’ dangerous side effects among the young.

Today, there is significant progress taking place in developing better treatments for children with cancer. This is not due solely to the work of the researchers, as regulators, advocates, and industry stakeholders are working on new ways to speed drug discovery and approval methods.

Cancer research is imperative for defining the safety and efficacy of new medications and protecting youth from possible side effects when given medicine approved for adults. New legislation has prioritized pediatric drug research and development, which has led to a significant rise in the number of trials dedicated to creating medications for children.

With assistance from the FDA, cancer research protocols have improved and more emphasis has been put on developing effective drugs for cancer patients.

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Categories: Oncology

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