Loxo's accurate anticancer drug is submitted for marketing application December 21, 2017 Source: WuXi PharmaTech Bayer announced today that Loxo Oncology, a partner of the company, has begun to submit a new rolling application (NDA) for larotrectinib to the US FDA. Larotrectinib will be used to treat adult or child solid tumor patients carrying the NTRK fusion gene. Their tumors cannot be removed or have metastasized, require systemic treatment, and the symptoms continue to worsen or have no other treatment options after receiving other therapies. The tropomyosin receptor kinase (TRK) signaling pathway is an important signaling pathway regulating cell communication and tumor growth, while NTRK is a gene encoding TRK. In rare cases, the NTRK gene fuses with other genes, resulting in an uncontrolled TRK signaling pathway that promotes tumor growth. Larotrectinib is an oral, potent and selective TRK inhibitor developed by Bayer and Loxo. By directly targeting TRK, it can turn off signaling pathways that promote tumor growth. Larotrectinib has been awarded the FDA for breakthrough therapeutic identification and orphan drug status, and has shown good efficacy in cancer patients carrying the TRK fusion gene in several clinical trials. At this year's annual meeting of the American Society of Clinical Oncology (ASCO), Loxo released data on the efficacy of larotrectinib. The data showed that 76% of patients with TRK-fused tumors achieved objective response (ORR). â–²Larotectinib molecular structure (Source: Wikipedia) "More and more studies have shown that TRK is a potential target for the treatment of cancer. Although TRK fusion is very rare, it is widely found in a wide variety of rare tumors in adults and children," said Carsten Brunn, president of Bayer USA. Mr. said: "We are very pleased to start the rolling new drug application process for larotrectinib, which brings us one step closer to the goal of delivering this treatment option to patients." Loxo Oncology expects to complete the NDA application in early 2018. Reference materials: [1] Bayer Announces that Loxo Oncology, Inc., Initiates Rolling NDA Submission for Larotrectinib for the Treatment of TRK Fusion Cancers [2] Loxo Oncology Official Website Sodium Erythorbate Fcc Grade,Sodium Erythorbate Powder,Sodium Erythorbate Food Additive,Food Grade Sodium Erythorbate SHANDONG BAISHENG BIOTECHNOLOGY CO., LTD , https://www.baishengbioproducts.com
