FDA for a treatment of advanced non-small cell lung cancer (NSCLC) in patients with oral drug granted accelerated approval

US FDA for a treatment of advanced non-small cell lung cancer (NSCLC) in patients with oral drug granted accelerated approval. Tagrisso (osimertinib) is now approved for use in tumor specific epidermal growth factor receptor (EGFR) mutation (T790M), and patients with other EGFR inhibitor treatment after disease progression.
Lung cancer is the major cause of death in the United States, according to information provided by the National Cancer Institute, in 2015 an estimated 221,200 new cases diagnosed, there are 15.804 million people will die from the disease. Non-small cell lung cancer is the most common form of lung cancer, when the cancer cells in the lung tissue formation occurs non-small cell lung cancer. EGFR gene is a participation in the growth and spread of cancer cells a protein.
"We are the molecular basis of lung cancer and these cancers become resistant to previous treatments cause of rapid progress in understanding the positive," oncology office, Dr. FDA Center for Drug Evaluation and Research, said blood and medical Pazdur. "The ratification of resistance mutations in patients with EGFR-positive (T790M) testing was to provide a new therapeutic drugs, the approval of substantial evidence-based clinical trials, these clinical trials have shown that more than half of Tagrisso in patients with prior treatment shrink tumors have a significant effect. "
Today, FDA also approved to detect targets -EGFR Tagrisso known resistance mutations associated with the first type of diagnostic tests (cobaseGFR Mutation Test v2). Version (v2) for the initial detection of the latest approved CobaseGFR Mutation Test (v1) detection of clinically relevant mutations increase the T790M mutation.
"In the cancer field, along with a safe and effective diagnostic testing and drug approval is still important progress" in vitro diagnostic devices and radiological health centers FDA and Radiation Health Office, Ph.D., Gutierrez said. "CobaseGFR Mutation Test v2 availability to meet this significant demand for EGFR gene mutations, which can change the therapeutic effect."
safety and effectiveness agrisso in two multi-center, single-group study was confirmed, the subject of these two studies after 411 in an EGFR-blocking drugs treat disease progression EGFR T790M mutation positive advanced non-small cell lung cancer patients. These two studies, the first study 57% of patients and 61% of study patients experienced a second tumor completely or partially reduce shrink (objective response rate). Further validation studies continue approved for this indication may be based.
Tagrisso most common side effects are diarrhea, skin and nail disorders (such as dry skin), infections or rashes and redness around the nail. Tagrisso may cause serious side effects including lung inflammation and heart damage. The drugs also may cause harm the developing fetus.
FDA grants AstraZeneca Tagrisso breakthrough drugs qualifications, priority review and orphan drug eligibility qualifications. Awarding breakthrough drugs that are designed to treat serious diseases, drugs listed in the application materials submitted, preliminary clinical evidence that the drug with existing therapies may prove a substantial change compared to.
Granted priority review of eligibility to apply for those drugs for the treatment of serious diseases in safety or efficacy show a significant improvement. Orphan status can provide incentives, such as tax credits, fee waivers and the applicant qualifications market exclusivity, thereby helping and encouraging the development of drugs for rare diseases.
Tagrisso in FDA approved under accelerated approval program, based on accelerated approval to allow the display of a drug on a reasonable proxy may be used to predict clinical benefit endpoint effective clinical data to approve a serious or life-threatening disease that drug treatment. This program allows patients earlier access to promising new drugs, but the drug applicants while confirmatory clinical trials to be carried out.
Tagrisso by the Wilmington, Delaware AstraZeneca marketed. CobaseGFR Mutation Test v2 by the California Roche Molecular Systems in Pleasanton sale.