The global research biopharmaceutical company AbbVie has announced the decision of the Ministry of Health of the Russian Federation to expand the indications for the use of Venclexta (INN: venetoclax), a selective inhibitor of anti-apoptotic B-cell lymphoma protein (BCL-2), for the treatment of Small Lymphocytes Lymphoma (SLL).
SLL became the third indication for the use of AbbVie’s drug, along with chronic lymphocytic leukemia (CLL) and acute myeloid leukemia.
This approval is based on the report on the clinical trial M12-175, which involved two groups of patients: group A, which included patients with CLL/SLL, and group B, which included patients with non-Hodgkin’s lymphoma (NHL). Additionally, the clinical recommendations “Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma”, approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, as well as recommendations on clinical practice in oncology (NCCN Guidelines®) “Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma”, approved in the USA, were presented as justification for the amendment. In addition, CLL and SLL have been also approved as indications in the instructions for the medical use of the drug in the USA.
“Every year, more than 19.3 million new cases of malignancies are registered in the world. In 2020, more than 474,000 new cases of leukemia and more than 311,000 deaths from leukemia were recorded. We see our mission in expanding the experience of treatment of various types of hematological diseases in order to save lives of thousands of patients. Therefore, the approval of a new indication of Venclexta is an important step on this path, and we do not intend to stop and are only moving forward to expand the company’s oncology portfolio,” commented Dmitry Koloda, AbbVie Medical Director in Russia and the CIS.
For the therapy of SLL, as well as for the therapy of CLL, Venclexta is available in Russia in the form of film-coated tablets of 10 mg, 50 mg, and 100 mg.