FDA accelerates approval of no-limit cancer targeting therapy for the treatment of NTRK fusion tumors


Recently, LOXO Oncology and Bayer jointly announced that the FDA has accelerated the approval of a co-developed VITRAKVI (larotrectinib) listing for the treatment of adults and children with locally advanced or metastatic solid tumors carrying NTRK gene Fusion, There is no need to consider the area where the cancer occurs.


The approval of the drug is an important milestone in the evolution of cancer therapy from "based on the origin of cancer in the body" to "tumor-based genetic characteristics". In the fusion tumor of proto-myosin receptor kinase (TRK), the NTRK gene fuses with unrelated genes, resulting in the production of mutated TRK proteins. The mutated trk or TRK fusion protein continues to activate, triggering a permanent signal cascading reaction. These proteins are a major driver of tumor growth and metastasis in patients with TRK fusion cancer. TRK Fusion carcinoma is not limited to a particular cell or tissue type, it can be present in any part of the body. The types of tumors that develop NTRK gene fusion include breast cancer, colorectal cancer, lung cancer, thyroid cancer, and so on.


Cancer patients need to undergo a specific test based on next-generation sequencing or immunohistochemistry to confirm whether they are carrying trk fusion cancer. Larotrectinib is a new generation of highly specific oral TRK inhibitors developed by LOXO Oncology and Bayer. It is a new anticancer drug that has targeted specific genetic mutations since the early stages of development, rather than specific cancer species. It has been identified by the U.S. FDA's groundbreaking therapies, orphan drug eligibility and rare pediatric disease identification. Moreover, in the course of drug development, clinical trials to test the efficacy of the drug also used the experimental design of the "basket test" (basket trial).

That is, not according to the cancer tissue to raise patients, but according to the molecular characteristics of the tumor to raise patients.