The FDA approved Qinlock as a four-line treatment for advanced gastrointestinal mesothelioma

Recently, the U.S. Food and Drug Administration (FDA) approved the Qinlock tablet as the first new drug to be specifically approved for four-line treatment of advanced gastrointestinal mesothelioma, a tumor that originates in the gastrointestinal tract. Qinlock is suitable for adult patients who have received three or more kinase inhibitor therapies, including imatinib.“ Despite the progress made over the past 20 years in the development of gastrointestinal mesothelioma therapies, including four FDA-approved targeted therapies - imatinib in 2002, schoiniinib in 2006, rigoffinib in 2013 and Avaprini earlier this year - some patients did not use it, and tumors continued to develop. Today's approval provides a new treatment option for all patients who have exhausted FDA-approved gastrointestinal mesothelioma therapy," said Dr. Richard Pazdur, Director of Evaluation and Research at the FDA Center of Excellence in Oncology and Acting Director of the Office of Oncology at the FDA Drug Center.Every year, between 4,000 and 6,000 adults in the United States are diagnosed with gastrointestinal mesothelioma. Gastrointestinal mesothelioma occurs when abnormal cells form in the gastrointestinal tissue. Gastrointestinal mesotheliomas are most common in the stomach, small intestine and large intestine, but can start anywhere in the gastrointestinal tract.Qinlock is a kinase inhibitor, which means it works by blocking an enzyme called kinase, which helps stop cancer cells from growing.Qinlock's approval is based on the results of an international, multi-center, randomized, double-blind, placebo-controlled clinical trial that recruited 129 FDA-approved targeted treatments, imatinib, schoinib and regofinib. The trial compared patients who received Qinlock randomly with patients who received a placebo at random to determine whether the progression-free lifetime (PFS) - from the initial treatment of clinical trials to the time of cancer growth or death - was longer than in the placebo group. During the course of treatment in this trial, patients were treated with Qinlock or placebo once a day for a 28-day cycle, repeating treatment until tumor growth (disease progression) was detected or patients experienced unbearable side effects. After the disease progresses, patients randomly assigned a placebo can choose to switch to Qinlock.On average, the PFS rate was 6.3 months in the Qinlock group and 1 month in the placebo group.The most common side effects of Qinlock are hair loss (hair loss), fatigue, nausea, abdominal pain, constipation, muscle pain, diarrhea, decreased appetite, palm-erythema abnormality syndrome (skin reaction in the palm and soles of the foot) and vomiting Qinlock can also cause serious side effects, including skin cancer, hypertension (hypertension) and cardiac dysfunction, as shown by lower blood score (when the left heart muscle pumping is abnormal). Health care providers should routinely check for these symptoms and signs, as well as other risks of Qinlock.Qinlock may cause harm to a developing fetus or newborn baby. Health care professionals should advise pregnant women to be aware of this risk and male patients with reproductive capacity and female partners should use effective methods of contraception during treatment and within one week of the last medication. Patients are advised not to breastfeed when taking Qinlock.The FDA awarded the application the title of "priority review" and "fast track" and "breakthrough therapy" to accelerate the development and review of drugs designed to treat serious diseases when preliminary clinical evidence indicates that the drug can demonstrate substantial improvement over existing therapies. Qinlock was also awarded the title of "Orphan Drug", which aims to encourage and encourage the development of rare disease drugs. The review used a "real-time oncology review" that simplifies data submission before the entire clinical application is submitted, as well as "assessment assistance," which is voluntary and is intended to facilitate FDA evaluation.The FDA is working with the Australian Therapeutic Products Authority (TGA) and Health Canada to review the project as part of the Orbis program. The FDA approved Qinlock three months in advance. Applications are being reviewed by TGA Australia and Health Canada.FDA approves Deciphera Pharmaceuticals' drug Qinlock. (cyy123.com)