Another "unlimited cancer" anti-cancer drug has been approved clinically in China

Bayer inc. has applied for an implied license to develop tumors in adults and children for NTRK fusion, according to the latest announcement from the National Drug Administration's Drug Evaluation Center (CDE).
public information shows that selitrectinib is an "unlimited cancer" candidate drug, LOXO-195, from Loxo Oncology (which has been acquired by Lilly), developed in cooperation with Bayer, and that selitrectinib inhibits the activity of TRK proteins that are already resistant to existing TRK inhibitors, according to selic Results from an early clinical trial in Tinib showed that selictinib received an objective remission rate (ORR) of 45% in 20 patients who had been treated with a TRK inhibitor, and that it was also able to treat patients with solid tumors that were resistant to the oral TRK inhibitor Larotrectinib (commodity name Vitrakvi).
TRK, also known as neurotrophic receptor tyrosine kinase (NTRK), is a class of neurogasome factor receptors that contain the NTRK1, NTRK2, and NTRK3 gene-coded TrkA, TrkB, and TrkC receptors.
TRK kinase is closely related to cell proliferation, differentiation, metabolism and apoptosis.
that when chromosomal mutations occur in the fusion of the NTRK gene, it can lead to overactivation of downstream signals of TRK kinases, which can lead to cancer.
NTRK gene fusion can be found in a variety of solid tumor types, including pancreatic cancer, thyroid cancer, salivary adenocarcinoma, breast cancer, colorectal cancer, lung cancer, etc., especially in some rare cancers, such as infant fibroblastoma, similar to breast secretion cancer, breast secretion type cancer, the incidence of NTRK gene fusion can reach more than 90%.
So far, a number of "unlimited cancer" drugs have been approved, including Larotrectinib, also developed by Loxo/Bayer, a new generation of highly specific oral TRK inhibitors, and a broad-spectrum tumor drug that has been targeted at specific gene mutations since early development, not specific to specific cancer types, and can be used for all tumor patients who express protoglobulin-specific kinases, rather than for anatomical locations.
In November 2018, the FDA accelerated the approval of Theratrectinib for the treatment of adult and child solid tumor patients without known drug-resistant mutations, with poor results from extensive metastasis or local surgery, advances in existing treatment options or irreplaceable treatment options, NTRK gene fusion.
Roche's Entrectinib is a specific tyrosine kinase inhibitor designed for NTRK and ROS1 gene fusion, which inhibits TRKA/B/C and ROS1 kinase activity, and test data show that Entrectinib is more than half (57.4%) more than half (57.4%) more positive for NTRK gene fusion. Tumors in patients with local progression or metastatic solid tumors with a response time (DoR) of 2.8 to 26 plus months were effective for breast cancer, bile tube cancer, colorectal cancer, gynecological tumors, neuroendocrine tumors, non-small cell lung cancer, salivary gland cancer, pancreatic cancer, sarcoma, thyroid cancer and other solid tumors.
August 2019, Entrectinib was approved by the FDA to treat adult and child solid tumor patients with NTRK gene fusion without other effective treatments, as well as patients with ROS1-positive non-small cell lung cancer (NSCLC).
it is understood that both Larotrectinib and Enterinib have been approved for clinical trials in China, with Larotrectinib obtaining implied permission for clinical trials in March 2019 for locally advanced or metastasis solid tumor patients with NTRK fusion genes.
Entrectinib obtained an implied license for three bed trials in November 2020 to develop indications for the treatment of non-removable, locally advanced or metastatic solid tumor patients carrying specific carcinogenic gene changes or potential predictive biomarkers.
, the product was approved for several clinical trials in China.
In addition, Pembrolizumab is also a "broad-spectrum anti-cancer drug", which is a humanized PD1 monoantitor, has been approved by the FDA for lung cancer head and neck cancer, liver cell carcinoma, kidney cancer, cervical cancer, stomach cancer, melanoma, esophageal cancer and many other cancers.
It is worth noting that so-called broad-spectrum anti-cancer drugs are not intended to treat all cancers, nor are they intended to cure cancer, but simply that they are intended to cover a relatively longer number of types of tumors than previous cancer drugs, which are usually only available for specific types of tumors based on the location of the disease.
At present, there are no "unlimited cancer" therapy approved, but domestic products have been approved clinically, respectively, No cheng Jianhua's ICP-723 and Beida Pharmaceuticals independently developed TRK inhibitor BPI-28592, adaptors are late-stage or metastatic NTRK gene fusion of solid tumor patients.
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