On August 26, news came from home that the precision treatment drug ivosidenib of cornerstone Pharmaceutical (Hong Kong stock exchange code: 2616), a Hong Kong stock listed innovative pharmaceutical company, was approved by the U.S. Food and Drug Administration (FDA) to be used for adult patients with locally early or metastatic cholangiocarcinoma with IDH1 gradient detected by the FDA approved test method. This symbolizes that avonib has become the first drug approved by FDA for targeted treatment of IDH1 patients with graded cholangiocarcinoma. Not only that, on August 26, news came from home that the precision treatment drug ivonidenib of cornerstone Pharmaceutical (Hong Kong stock exchange code: 2616), a Hong Kong stock listed innovative pharmaceutical company, was approved by the U.S. Food and Drug Administration (FDA), For previously treated adult patients with locally early or metastatic cholangiocarcinoma with IDH1 gradient detected by FDA approved detection method. This symbolizes that avonib has become the first drug approved by the United States for targeted treatment of IDH1 patients with progressive cholangiocarcinoma.
Not only that, avonib's remedial new drug application (SNDA) received priority review, which greatly extended the review time. Priority reviews are usually given to drugs that can provide treatment in an environment where there is a serious pause in treatment or where there are insufficient treatment techniques.
It is understood that this time, the payment of priority evaluation qualification is based on the phase 3 clinical trial data named claridhy. The study is the first randomized phase 3 study in the world for patients with treated cholangiocarcinoma with IDH1 gradient. The experimental results showed that compared with the placebo group, the avonib treatment group reached the secondary end point of non-stop life cycle (PFS), greatly reducing the risk of disease pause or death. At the same time, avonib also improved the total life span (OS).
Cholangiocarcinoma is a common malignant tumor, which occurs in the bile duct outside the liver. It is estimated that 8000 people in the United States are diagnosed with cholangiocarcinoma every year. Prior to the consent of avonib, no targeted treatment for IDH1 progressive cholangiocarcinoma has been agreed, and in the early environment, there are unlimited chemotherapy options.
Cornerstone pharmaceutical has the exclusive right to develop and trade in China, including Mainland China, Hong Kong, Macao and Taiwan, and Singapore. Previously, avonib was included in the "list of clinically urgently needed overseas new drugs (the third batch)" announced by the drug review center of China's State Drug Administration (nmpa).
At present, in China's great marine area, cornerstone pharmaceutical is carrying out two registered clinical seminars on avonib, mainly for acute myeloid (AML) compliance. Among them, cs3010-101 seminar is an ongoing phase I, multi intermediate, one arm seminar for adult R / R AML patients with susceptible IDH1 gradient in China, and serves as a bridge seminar for global crux seminar ag120-c-001. China's National Drug Administration (nmpa) has accepted the application for new drug marketing of avonib for adult patients with R / R AML susceptible to IDH1 gradient and classified it into priority review.
Another study, age, is a global phase III, multi intermediate, double-blind, randomized, placebo control, which aims to evaluate the efficacy and safety of avonib combined with azacytidine and placebo combined with azacytidine in previously untreated AML patients with IDH1 gradual change. Servier recently released the age seminar, which reached the secondary end of the life without change (EFS).
It is understood that in addition to the two indications of acute myeloid leukemia and cholangiocarcinoma, the research on the use of avonib in the treatment of patients with glioma is also surging, and has shown considerable potential for treatment.
It is worth noting that although avonib has not been approved internationally, it has made a serious breakthrough in the dimension of drug accessibility early. Previously, avonib was included in Beijing Pratt & Whitney health insurance as one of 75 Hainei special drugs, and in Hainan Boao Lecheng global special drug insurance as one of 25 international drugs, which symbolizes that more patients can benefit from it and greatly improve the affordability of drugs（ bioon）
