Non-limiting cancer-type heavy-weight targeted drugs were declared clinically accepted in China

, industry news that the company's heavyweight "unlimited cancer" target drug, Vitrakvi, which was bought by Lilly for $8 billion a few days ago, has declared clinical trials (INDs) in China and has been accepted. It comes less than two months after the drug was approved by the FDA and just a week after Loxo was acquired by Lilly. According to information posted on the website of the Drug Review Center (CDE) of the National Drug Administration, the IND application for the drug under the name "Larotrectinib Capsules sulfate" was filed by Bayer and was accepted on 14 January 2019 with the following information:
Larotrectinib is a new generation of highly specific oral TRK inhibitors developed by Loxo Oncology and Bayer. The biggest point of view of the drug is that it is a new cancer drug that targets specific gene mutations, not specific types of cancer. The NTRK gene fusion solid tumors that can be treated include breast, colorectal, lung, thyroid and other types of cancer. As a result, Larotrectinib's approval in the United States is considered an important milestone in the evolution of cancer therapy from "based on the origin of cancer in the body" to "based on the genetic characteristics of tumors". The drug, which has previously been recognized by the FDA as a breakthrough therapy, is eligible for orphan drugs and rare pediatric diseases, and was accelerated by the FDA in November to treat adult and child patients with localized advanced or metastasis solid tumors that carry NTRK gene fusion, regardless of the area where the cancer occurs.
that the clinical trials at larotrectinib were designed using the "basket trial". That is, not according to the cancerous tissue to raise patients, but according to the molecular characteristics of the tumor to raise patients. According to data released at the annual meeting of the European Society of Oncology (ESMO) in October 2018, larotrectinib achieved an objective remission rate (ORR) of 80% among 55 patients with TRK fusion cancer measured by RECIST. Moreover, its performance is very consistent among many types of cancer.
further progress in the global registration of the drug by the company's technology company, Larotrectinib, to be declared clinically and accepted in China. It is hoped that the new drug will be able to carry out clinical trials in China as soon as possible, and that clinical research will be carried out smoothly to bring new treatments to cancer patients in China as soon as possible. (Bio Valley)