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On March 14, 2022, CStone pharmaceuticals announced that the application for extended indications for the selective RET inhibitor Phukethua (pratinib capsules), known in English as prasetinib, has been approved by the State Drug Administration of China (NMPA).
The drug is used to treat adults and children 12 years of age and older with systemic advanced or metastatic transfection rearrangement (RET) mutant medullary thyroid carcinoma (MTC) and children 12 years of age and older, as well as advanced or metastatic RET fusion-positive thyroid cancer (TC) and children 12 years of age and older who require systemic therapy and are refractory to radioactive iodine (if radioactive iodine is applicable).
Previously, in March 2021, the State Drug Administration approved Phuket Hua for locally advanced or metastatic non-small cell lung cancer (NSCLC) that had previously received RET fusion positive with platinum-containing chemotherapy, and with this successful expansion, Phuket Hua is also the first and only selective RET inhibitor approved for RET mutation MTC and RET fusion positive TC in China.
1. Treatment of RET+ advanced thyroid cancer
Introduction to thyroid cancer
Thyroid cancer begins with the thyroid gland, a butterfly-shaped organ that produces hormones to help regulate heart rate, metabolism, blood pressure, and body temperature. Tumors metastasize to other parts of the body as the thyroid gland progresses.
The abnormal RET gene may be found in several types of advanced thyroid cancer, including medullary thyroid cancer (MTC), thyroid cancer (PTC), follicular thyroid cancer, and Hurthle cells, but it is most commonly found in MTC and PTC. MTC is a less common type of thyroid cancer. Approximately 90% of cases of advanced MTC are RET+.
RET and advanced thyroid cancer
RET is a gene that everyone has inside a cell. Providing instructions to cells in the human body is equivalent to the brain controlling the reproduction and growth of cells. While the gene for RET within cancer cells is abnormal, abnormal RET genes, such as RET fusion or mutation, drive uncontrolled growth of cells, leading to cancer. If advanced thyroid cancer is caused by an abnormal RET gene, it is called RET positive (RET+).
Phuket Hua's mechanism of action and efficacy
After understanding the causes of RET thyroid cancer, it is not difficult to find that the fundamental problem of this disease is the abnormal RET gene. The treatment should be cut from the RET gene.
When Phuketa works in vivo, it blocks uncontrolled growth of cancer cells driven by abnormal RET genes. Slows the growth and spread of cancer.
The ARROW study is a global clinical study designed to evaluate the safety, tolerability and efficacy of pratinib in patients with RET fusion-positive NSCLC, RET mutant medullary thyroid carcinoma and other advanced solid tumors fused with RET fusion.
The clinical data of the experiment showed that the overall response rate (ORR) of the patients was 56%, the median duration of remission (DOR) was not reached, the DOR rate at 6 months was 83%, the safety and tolerability were good, and there were no adverse events leading to the cessation of the experiment. The data demonstrate that the drug has superior and long-lasting anti-tumor activity.
2. RET positive (RET +) non-small cell lung cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is a common form of lung cancer. If the cancer is driven by an abnormal RET gene, it is called RET positive (RET+).
The RET gene is the same as mentioned above, inside the tumor, when the RET gene breaks and reconnects to another gene, it becomes a RET fusion.
RET fusion may be seen in non-small cell lung cancer (NSCLC), which is known to drive uncontrolled cell growth, leading to cancer.
After the test of time, Phuket's objective response rate is as high as 73%, the objective response rate has reached 61%, and the disease control rate (DCR) has reached 93%!
3. Prospects and prospects
As the first and only treatment program for the RET gene in China, Phuket Hua has shown excellent anti-tumor activity in the treatment of thyroid cancer and non-small cell lung cancer. With its approval and listing, it will bring more choices to domestic cancer patients. More authoritative information medical companion travel for you to continue to update.