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Recently, AbbVie BCL-2 inhibitor "Venecla tablet" market application (JXHS2000002/3/4) entered the administrative approval stage, which means that the drug will soon be approved in China, approved adaptation Symptoms are: combined aza cytosine, or tesythytoside, or low-dose agarose cytosine is used to treat patients with acute myeloid leukemia (AML) in adults aged 75 years and older or who are not suitable for a new diagnosis of strong induced chemotherapy due to co-merger.
venetoclax is an selective B-cell lymphoma factor-2 (BCL-2) inhibitor developed by AbbVie and Genetek.
BCL-2 play an important role in apoptosis (programmed cell death) to prevent apoptosis of some cells, including lymphocytes, and overexposed in some types of cancer, associated with the formation of drug resistance.
is designed to selectively inhibit the function of BCL-2, restore cell communication systems, allow cancer cells to self-destruct, and achieve the goal of treating tumors.
April 2016, venetoclax was approved by the FDA to treat patients with chronic lymphoblastic leukemia (CLL), which carries 17p deficiency and has been treated at least once, and became the first FDA-approved BCL-2 inhibitor.
October 2016, the drug was approved in the European Union under the trade name Venclyxto.
, AbbVie and Roche are jointly responsible for the commercialization of the drug in the U.S. market, and AbbVie is responsible for the commercialization of the drug outside the U.S. market.
, venetoclax has been approved for listing in several countries around the world, including CLL, small cell lymphoma (SLL), acute myeloid leukemia (AML).
Venclexta's annual sales are growing year by year, with global sales of $344 million and $792 million in 2018 and 2019, respectively, and sales of $972 million in the first three quarters of 2019, according to AbbVie's earnings report.
, venetoclax's soon-to-be-approved adaptation at home was accelerated by the FDA in 2018 and fully approved by the FDA in October.
the adaptation was based on data from Phase 3 study VIALE-A (M5-656) and VIALE-C (M16-043), Phase 1b study M14-358, and Phase 1/2 study M14-387.
VIALE-A study was conducted in patients with AML who had not yet received treatment and were unable to withstand traditional intensive chemotherapy and newly diagnosed AML, comparing the efficacy and safety of the placebo-Aza cytosine (AZA, a low methylated agent) and venetoclax-azatase.
results showed that the venetoclax-Azatosin solution significantly extended the total lifetime (OS) compared to placebo-azadesin.
specific efficacy data were: (1) compared to the Azadesin-placebo group, the venetoclax-Azatosine treatment group OS significantly extended (medium OS: 14.7 months vs. 9.6 months), reduced the risk of death by 34% (HR=0.66; 95% CI: 0.52-0.85; p<0.00).
(2) was more than twice as likely (66.4% vs. 28.3% p<0.001) of the venetoclax-azac cytosine treatment group (CR-CRi) compared to the Azatosin-placebo group.
In addition, the study also reached the secondary endpoint of CR-CRh (full remission and partial hematological recovery): 64.7 percent in the venetoclax-Azatosine treatment group and 22.8 percent in the Azadesin-placebo group.
and the VIALE-C study was conducted in newly diagnosed AML patients who did not qualify for intensive chemotherapy.
study, patients were randomly assigned to compare the efficacy and safety of the venetoclax-LDAC scheme, the placebo-LDAC scheme (n-68), and the main endpoint of the treatment was to compare the two groups of OS.
the study did not achieve a significant improvement in OS, although the overall mitigation rate increased significantly to 27% in the pilot group, compared with 7.4% in the control group.
11.1 months from 8.3 months for full mitigation.
AML is a type of cancer caused by abnormal growth of primitive and infantic myelin cells in bone marrow and exoded blood, mainly in the elderly.
currently, the standard treatment for AML is strongly induced chemotherapy, followed by solid chemotherapy or isotope stem cell transplantation.
Because of age, syncytiality, and the risk of adverse genetic mutations, many older patients are unable to receive standard chemotherapy or become resistant to it, using low methylated agents (e.g., azatide) and low-dose chemotherapy, and patients who receive this treatment usually live less than a year.
statistics, China adds about 40,000 new AML patients each year, more than the total number of new cases in Europe, the United States and Japan.
we look forward to the early approval of Venacla in China for the benefit of domestic AML patients.
addition, venetoclax has also been developed domestically for the treatment of chronic lymphocytic leukemia and multiple myeloma, as detailed in the table below.
addition to Venecla, there are currently a number of Bcl-2 inhibitors in the country, such as APG-1252 (Bcl-2/Bcl-xL inhibitors), APG-2575 (Bcl-2 selective inhibitors) and AT-101 (Bcl-2) /Bcl-xL/Mcl-1 Pan-Inhibitor), BGB-11417 of Baiji Shenzhou, FKN-338 of Fosun Pharma, LP-108 of Peng Pharmaceuticals, of which AXA Pharmaceuticals' APG-2575 was awarded by the FDA as an orphan drug for the treatment of Fahrenheit's pyrethroids.
It is also worth mentioning that in October, Fosun Pharma granted Lilly exclusive rights to FCN-338's global interests outside Chinese mainland, Hong Kong and Macau in a deal valued at $440 million.