FDA: approval of specific cancer drugs will be accelerated!

Source: Wuxi apptec Co., Ltd on December 4, 2017, Dr Scott Gottlieb, director of FDA, and Dr Francis Collins, President of NIH, recently held a meeting with the House Energy & Commerce Committee on how to implement the 21st century cures Act), signed by President Obama a month before he leaves office The hearings focused on a huge new law, including the FDA's major changes to drugs, devices and biologics, and provided the agency with $500 million in executive funding over a decade Dr Scott Gottlieb (photo source: Wikipedia) in an open comment, Dr Gottlieb told the committee that the FDA is developing a proposal that has been approved for an indication of cancer therapy, which can be approved for a second indication by submitting a supplementary application based on a more targeted data set (such as a single arm study) Dr Gottlieb added, "the proposal is applicable when the treatment effect is obviously effective, and the second indication involves the same disease as the first one but is applied to the new scene For example, a targeted drug approved for third-line treatment shows the benefits of second-line treatment " In the Q & a part of the hearing, Dr Gottlieb mentioned that another new guideline on "targeted therapy" will be released "soon" on how drugs targeting biomarkers can be approved, "such as cancer that may appear in multiple organs." Dr Gottlieb also pointed out that since the adoption of the food and drug administration safety and innovation act (fdasia), the FDA has been able to accelerate the approval of new drugs to market according to the intermediate clinical endpoints "We want to better define the meaning of the intermediate end point and ensure that potential drug developers take full advantage of this provision and consider it in a broader context," he said In praising the FDA's Oncology Center of excellence (OCE), Dr Gottlieb added that with the help of the agency, two new car-t cell therapies have recently been approved, namely, kymeriah (tisagenlecleucel) of Novartis and yescarta (axicabagene ciloleucel) of kit pharma He said the two treatments could be transformative The 21st century healing act, signed on December 13, 2016, aims to help accelerate the development of medical products and bring new innovation and progress to patients who need to be faster and more effective The bill is based on the FDA's new drug approval system, which brings patients' perspectives into the development of drugs and biological products The purpose of the FDA oncology Excellence Center is to accelerate the development of oncology and hematology medical products and support the use of integrated methods in clinical evaluation of drugs, biologics, and cancer treatment devices.