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On August 26, the latest announcement on the CDE official website showed that Eli Lilly’s RET inhibitor Selpercatinib capsules are planned to be included in the priority review, which is suitable for transfection of locally advanced or metastatic non-small cell lung cancer patients with positive rearrangement gene fusion, and the need for systemic RET mutations Treatment of advanced or metastatic medullary thyroid carcinoma (MTC) adults and children 12 years and older, as well as RET gene fusion-positive adults and adults with refractory advanced or metastatic thyroid cancer that require systemic therapy and radioiodine therapy (if applicable) Treatment of pediatric patients 12 years and older
.
Screenshot from: CDE official website
Selpercatinib was developed by Loxo Oncology at Lilly, a subsidiary of Eli Lilly.
In the preliminary study of RET-positive NSCLC, 39 patients with RET fusion mutant NSCLC who have not received systemic treatment, after using LOXO-292, 85% of the patients' tumors shrank significantly; In 105 patients with RET fusion mutant NSCLC who developed resistance after chemotherapy, 64% of the patients' tumors shrank significantly again after using LOXO-292, and 81% of patients had a remission duration of at least 6 months; and selpercatinib was able to penetrate the blood-brain barrier It has a significant effect on patients with brain metastases
.
In May 2020, the US FDA approved the listing of selpercatinib for the treatment of adult patients with metastatic RET fusion-positive NSCLC, patients with advanced or metastatic RET mutant medullary thyroid cancer, or patients with advanced or metastatic RET fusion-positive thyroid cancer, becoming the first This model is approved for precision therapy for cancer patients carrying RET gene mutations
.
The approval is based on a global phase I/II trial LIBRETTO-001.
The RET gene is located on chromosome 10q 11.
2 and encodes a tyrosine kinase receptor consisting of 1100 amino acids, that is, RET protein.
The activation of its signal can be through the downstream STAT/PLCγ pathway to promote cell survival, migration and growth
.
The pathogenesis of RET-related tumors mainly includes RET gene alteration and abnormal expression of wild-type RET gene.
At present, many companies are planning to develop RET inhibitor drugs
.
In addition to Eli Lilly, foreign companies under research include Bayer, Roche, Takeda, Boston Pharmaceuticals, Helsinn Healthcare, NantCell, NantKwest, Nerviano Medical Sciences, and Taiho Pharmaceutical; domestic companies include CStone Pharmaceuticals, CP Tianqing, CSPC, and Osay Kang, Beida and Baekje
According to incomplete statistics, the global sales of targeted RET inhibitors currently on the market reach approximately US$5.
71 billion.
During 2020, sales of alectinib will be US$1.
21 billion and cabozantinib will be US$1.
06 billion.
Lenvatinib (lenvatinib) is 1.
04 billion U.
S.
dollars; single-target inhibitors pralsetinib (pralsetinib) and selpercatinib are late to market, and their sales contribution is small
.
By 2025, the overall market size of targeted RET inhibitors is expected to be close to US$11.
