Takeda ALK inhibitor has been given priority by FDA in the treatment of specific non-small cell lung cancer patients

Takeda announced Thursday that the US FDA has accepted the company's SNDA application for the listing of additional new drugs for arunbrid, and has granted it priority for review This application seeks to expand the scope of alunbrid as a first-line treatment for ALK positive non-small cell lung cancer (NSCLC) Alunbrid is the next generation tyrosine kinase inhibitor (TKI) developed by Takeda company, which is designed to target and inhibit the abnormal ALK activity caused by ALK gene change NSCLC is the most common type of lung cancer Among NSCLC patients, 3-5% of them carry ALK gene rearrangement which is the main factor driving the development of cancer, and alk inhibitors are particularly effective for them Alunbrag is the next generation tyrosine kinase inhibitor (TKI) developed by Takeda Its design has targeted and inhibited ALK fusion protein In April 2017, it received FDA's accelerated approval to treat patients with ALK positive metastatic NSCLC These patients continued to progress after receiving crizotinib treatment This SNDA is based on the results of phase 3 clinical trial alta-1l In this open label, randomized, multicenter, phase 3 clinical trial, 275 patients with advanced or metastatic NSCLC positive for ALK were treated with alunbrid or crizotinib These patients have not been treated with ALK inhibitors before The results showed that the progression free survival (PFS) was 29.4 months in the alunbrid group and 9.2 months in the active control group, according to the investigator's assessment For patients with brain metastases, PFS was 24 months in the alunbrid group and 5.6 months in the active control group Alunbrid also significantly improved the quality of life of patients "ALK positive NSCLC is a rare and serious lung cancer, which is very complicated to treat Although progress has been made, about 40000 patients worldwide are diagnosed with this disease every year, and there are still unmet needs, "Christopher, head of oncology treatment in Takeda "This is an important step in expanding the treatment options for ALK positive non-small cell lung cancer patients in the United States, and we look forward to continuing to work with regulators around the world to bring alunbrid to newly diagnosed ALK positive non-small cell lung cancer patients," said Dr Arendt reference material: [1] Takeda Announces U.S FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer Retrieved February 24, 2020, fromhttps:// Original title: first-line express delivery for specific non-small cell lung cancer patients, Takeda ALK inhibitor has been given priority review by FDA A kind of