The US FDA today approved the official launch of AstraZeneca’s new drug AZD9291! The trade name and common name of AZD9291 are called Tagrisso or Osimertinib. This is the third generation of TKI targeted drugs for the treatment of advanced non-small cell lung cancer, and its advent has brought good survival benefits to more lung cancer patients.
At the same time, experts from the Global Oncology Medical Network told patients that Tagrisso is only targeted at patients with non-small cell lung cancer EGFR mutations, and it is not the first choice for treatment. It must be treated according to the doctor’s requirements. Patients should not blindly go abroad for treatment.
AstraZeneca’s new drug AZD9291 is an oral small molecule third representative skin growth factor tyrosine kinase inhibitor (EGFR-TKI), which can simultaneously deal with EGFR gene mutations (including 18, 19, 21) Mutation) and EGFR-TKI acquired resistance (T790M). AZD9291, like WZ4002 and CO-1686, is also based on the pyrimidine skeleton, but there are differences. AZD9291 also has a certain lethality to EGFR wild tumor cells.
On November 13, 2015, the new oral drug Tagrisso (Osimertinib) was accelerated by the FDA for the treatment of patients with advanced non-small cell lung cancer (NSCLC). Tagrisso is used to treat non-small cell lung cancer that carries a specific epidermal growth factor receptor (EGFR) mutation (T790M), a disease that worsens after receiving other EGFR inhibitors.
According to the National Cancer Institute, lung cancer is the leading cause of cancer death in the United States. It is estimated that there were 221,200 new lung cancer cases and 158,040 lung cancer deaths in the United States in 2015. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. When cancer cells form in lung tissue, non-small cell lung cancer occurs, and the EGFR gene is a protein involved in the growth and spread of cancer cells.
If you want to participate in the clinical trial of new drug AZD9291 or receive new drug treatment, please log on to the Global Oncologist Network or call us at 4006667998.
Richard Pazdur, MD, director of the FDA’s Center for Drug Evaluation and Research, said: “We have a deeper understanding of the molecular basis of lung cancer and the causes of lung cancer resistance to previous treatments. This approval is positive for drug-resistant EGFR T790M mutations Of patients with non-small cell lung cancer provide a new treatment. According to a large number of clinical trials, Tagrisso has significantly reduced the tumors of more than half of patients. “
Today, the FDA has also approved the first nursing diagnostic test (coba seGFR mutation test v2) to detect targeted drug resistance EGFR mutations. The new batch version tested (V2) added the detection of the T790M mutation by the original coba seGFR mutation test (V1).
Dr. Alberto Gutierrez, Director of the Office of In Vitro Diagnostics and Radiological Health of the FDA Medical Devices and Radiation Health Center, said that “approving safe and effective nursing diagnostic tests and drugs is still an important advance in the field of oncology. Coba seGFR mutation test v2 can be used to detect EGFR Genetic mutations make treatment more effective. “
Tagrisso’s safety and effectiveness were confirmed by two multi-center demonstrations and single-arm research. A total of 411 advanced non-small cell lung cancers with EGFR T790M mutation were positive, and these patients all got worse after receiving EGFR blockers. After receiving Tagrisso, 57% of patients in the first study and 61% of patients in the second study achieved complete tumor elimination or partial shrinkage (known as the objective response rate).
The most common side effects of Tagrisso are diarrhea, dry skin, rashes, nail infections, or redness. Tagrisso may also cause serious side effects, including lung inflammation and heart damage. It may also harm the developing fetus.
The US Food and Drug Administration approved AstraZeneca’s Tagrisso as a breakthrough therapy, giving priority to reviewing eligibility and orphan drug designation. Breakthrough therapy specifies that the authorized drug is used to treat serious diseases. At the time of application, there is preliminary clinical evidence that this drug may show significant improvements in existing treatments. Priority approval is granted, mainly because the drug has significant safety or effectiveness in the treatment of serious diseases. Orphan drugs provide incentives such as tax relief, user fee reduction, and are eligible for market exclusivity to help and encourage drugs to develop drugs for rare diseases.
FDA approved the application of Tagrisso after an accelerated approval process. The accelerated approval process is used to approve drugs that treat serious or life-threatening diseases. If the drug can predict the clinical benefit of patients, and can affect the surrogate endpoint. This approval process allows patients to obtain new drugs that have the opportunity to be marketed one step earlier during the clinical trials of pharmaceutical companies.
Tagrisso is sold by AstraZeneca based in Wilmington, Delaware. Coba seGFR mutation detection v2 is sold by Roche Molecular Diagnostics in Pleasanton, California.
The FDA is an agency authorized by the US Congress, the Federal Government, and engaged in public health and public services to ensure the safety and effectiveness of human and veterinary drugs, vaccines, biological products, and medical devices. The agency is also responsible for the safety of the food supply, cosmetics, nutritional health products, and electronic radiation products in the United States and regulates tobacco products.
General pharmaceutical companies will give it a code name during the research phase. AZD9291 is its code name during the research phase. Once the drug is approved, there will be a clear trade name and generic name. The current trade name and generic name of AZD9291 are Tagrisso and Osimertinib).
