On June 21, Class 5.1 import application for 「Venetoclax tablet」 submitted by AbbVie was accepted by the CDE. Venetoclax tablet (VENCLEXTA ®), the first approved B-cell lymphoma-2 (BCL-2) inhibitor in China, was conditionally approved by NMPA in December, 2020 for treating the adult patients with Acute Myelocytic Leukemia (AML) who are not suitable for intensive induction chemotherapy due to complications or who are newly diagnosed at the age of 75 or older in combination with Azacitidine.
BCL-2 plays an important role in cell apoptosis (programmed cell death), which can prevent some cells (including lymphocytes) from apoptosis. And it can overexpress in some cancers, which is related to the drug resistance. Venetoclax makes cancer cells self-destruct to treat tumor by inhibiting the function of BCL-2 selectively and restoring the cell communication system.
At present, Venetoclax has been approved for several indications in America: Monotherapy for chronic lymphocytic leukemia (CLL) patients with 17p deletion mutation who have received at least one therapy before (FDA 2016/04); It combines with Rituxan to make a treatment for CLL or small lymphocytic lymphoma (SLL) patients with or without 17p deletion mutation who have received at least one therapy before (FDA 2018/06); It combines with a hypomethylated preparation (Azacitidine [AZA] or Decitabine [DAC]) or low dose Cytarabine (LD-AC) to make the first-line treatment for the newly diagnosed elderly AML patients at the age of 75 or older, or the adult AML patients who are not suitable for intensive induction chemotherapy due to other diseases at the same time (FDA 2018/11); It combines with Gazyva (Obinutuzumab) to make a treatment for adult CLL patients without any treatment before (FDA 2019/05).
In addition, in August 2022, the fixed treatment scheme of Venetoclax combined with Ibrutinib was approved by the EU for treating the adult CLL patients who are not treated before.
Venetoclax was developed by AbbVie and Roche, both of which are jointly responsible for its commercialization in the American market (Brand name: Venclexta), in which AbbVie is responsible for the commercialization of markets outside the America (Brand name: Venclyxto).
Venetoclax has a good market. According to the financial report of AbbVie, from 2018 to 2022, the sales volume of Venclexta is USD 344 million, USD 792 million, USD 1.337 billion, USD 1.82 billion and USD 2.009 billion respectively.
In China, Venetoclax is only approved for combining with Azacitidine to treat the newly diagnosed adult AML patients at the age of 75 or older or who are not suitable for intensive induction chemotherapy due to complications, and the above indication has entered the national medical insurance in 2022.
In addition to AML, Venetoclax has also been developed to treat recurrent or refractory CLL/SLL, recurrent or refractory multiple myeloma, myelodysplastic syndromes (MDS) and other diseases in China. The indication of Venetoclax which is declared this time in China is not yet clear, but this is one step closer to expanding the indication populations in China.
At present, only one BCL-2 inhibitor, Venetoclax, has been approved for marketing in global. In addition, many BCL-2 inhibitors under research in global have entered the clinical trial stage, as shown in the table below. Among them, AbbVie's Navitoclax is in a relatively fast progressing and has been in Phase III clinical trials.
![TERT-BUTYL 2-((1H-PYRROLO[2,3-B]PYRIDIN-5-YL)OXY)-4-BROMOBENZOATE; venetoclax intermediate](https://eimg.pharmasources.com/image/product/20221104/eda913da71a2cb00a946b09091200330jpg)
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