U.S. approves the first immunization drug targeting tumor molecular markers to break the inertia of cancer treatment
June 06, 2017 Source: Technology Daily
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Lung cancer drugs, intestinal gas cancer drugs, skin cancer drugs... These inertial thinking based on the diseased parts will soon be broken. The first accurate medical drugs targeting tumor molecular markers in the United States have recently obtained the US Food and Drug Administration (FDA). Quick approval.
The concept of precision medicine is to develop a personalized treatment plan based on the patient's genetic composition or other biological information. However, until now, cancer therapy has been based on clinical sites such as thymus or lung, and then applied to the FDA for approval.
On May 23, the FDA announced that it would extend the use of the PD-1 immunization drug Keytruda for all solid tumor patients expressing PD-1 protein variants. Ricardo Pazd, executive director of the Office of Hematology and Oncology Drug Approval of the FDA's Center for Drug Evaluation and Research, said in a statement that the approval is a milestone in cancer immunotherapy.
A large number of patients will benefit
Developed by pharmaceutical giant Merck, Keytruda is an immune drug that blocks PD-1 proteins and activates the immune system to attack tumors. In patients with PD-1 protein variants, the genes do not normally repair base mismatches in DNA, thereby inducing cancer. The FDA has used the fast track several times based on clinical data from different parts of the tumor to approve the drug for the treatment of skin cancer, head and neck cancer, non-small cell lung cancer and advanced rectal cancer.
Keytruda was accelerated this time based on clinical trial data from 149 patients with solid tumors at different sites: 40% of patients had partial or even complete disappearance of the tumor after administration. One of the 60-year-old patients with advanced ampullary cancer (a rare fatal gastrointestinal cancer) named Adrienne Skinner, born with a variant DNA repair gene, is ineffective in surgery and one-year radiation therapy. After that, he was selected to participate in the Keytruda clinical trial in 2014. After a few months of medication, she was told by the doctor when she was examined that her tumor had completely disappeared. Skinner insisted on taking the drug for two years and has now returned to normal. She not only finds full-time jobs, but also often goes to the gym to play tennis and do yoga.
Keytruda's new license will bring good news to a large number of patients. Although the FDA stipulates that Keytruda can only be used in advanced cancer patients whose other therapies have been ineffective, in the United States, 4% of advanced cancer patients carry the genetic variation of PD-1 protein, which is about 30,000 cases per year.
Breaking the traditional twists and turns
Over the past 10 years, with the advent of tumor-related gene and protein expression and other tumor markers, and their important role in tumor therapy, researchers have been hoping that the FDA can approve drugs based on cancer molecular markers such as Keytruda. Change your thinking and create a precedent. But after experiencing the initial passion, they had to go back to the reality of traditional thinking and study the effects of immune drugs on different diseased parts.
In 2010, researchers reported that the clinical effect of Vemurafenib, a drug that targets the variant protein B-RAF, is very good – a series of studies found that the drug is as effective as 48% for melanoma with this variant. . Genomic sequencing of different cancers has shown that many cancers contain this variant protein, and the researchers are delighted to conclude that these cancers can be treated with the drug. However, the drug was severely hit in subsequent clinical trials of colon cancer patients: only 5% of patients received efficacy after treatment. These frustrations have pulled researchers back to the traditional thinking of conducting drug clinical trials based on cancer sites.
Transforming drug development ideas
University of California cancer biologist Tver Bwana is excited to say that this is a landmark drug approval that marks the FDA, the company and oncologists to completely change their mindset and form a new drug development model. Biwana hopes that the FDA's approval will encourage more companies to increase the research and development of such immune drugs, so that different cancer patients carrying certain mutations can participate in the clinic, expand the scale of the trial, and screen out high-efficiency drugs faster.
The approval of Keytruda will also open a door for these immune drugs. A Stanford company in the United States is developing a drug that targets TRK-fusion proteins. The TRK-fusion protein is expressed by fusion of two genes and stimulates tumor growth. The company has conducted clinical trials of cancer patients carrying this fusion protein, which have different cancer sites, and the experimental data will be published at the annual meeting of the American Society of Clinical Oncology on June 3. (Nie Cuirong)
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