"Unlimited cancer types" therapy!

Article source: Pharmaceutical Guanlan

Today (November 9), the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Eli Lilly and Company had submitted a listing application for selpercatinib capsules in China and was accepted

Screenshot source: CDE official website

RET gene mutations include gene fusion and activating point mutations, which can lead to excessive activation of the RET signaling pathway and uncontrolled cell growth

Selpercatinib is a highly specific and potent oral RET inhibitor.

In China, selpercatinib has been approved for multiple clinical trials

In August 2020, the New England Journal of Medicine (NEJM) published the results of a Phase 1/2 registration clinical trial supporting selpercatinib's approval in the United States

Data from a Phase 1/2 clinical study of Selpercatinib in the treatment of thyroid cancer showed that among 55 previously treated patients with RET-mutated medullary thyroid cancer, the objective response rate was 69%, and the one-year progression-free survival rate was 82%; in 88 Among the RET-mutated medullary thyroid cancer patients who had not previously received treatment, the objective response rate was 73%, and the one-year progression-free survival rate was 92%; among the 19 patients with RET fusion thyroid cancer who received treatment, the objective response rate was 79%, the one-year progression-free survival rate was 64%

Public information shows that RET gene fusion occurs in about 2% of patients with non-small cell lung cancer, about 10-20% of thyroid cancer, and a few other cancer types

Note: The original text has been deleted

Reference materials:

[1] Drug Evaluation Center of China National Medical Products Administration.