THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION APPROVED THE EXTENSION OF INDICATIONS OF VENETOCLAX FOR THERAPY OF LYMPHOMA FROM SMALL LYMPHOCYTES

The global research biopharmaceutical company AbbVie announced a positive decision by the Ministry of Health of the Russian Federation to expand the indications for the use of Venclexta (INN: venetoclax), a selective inhibitor of the anti-apoptotic protein of B-cell lymphoma (BCL-2), for the treatment of small lymphocyte lymphoma (LML). LML is the third indication for AbbVie's drug alongside chronic lymphocytic leukemia (CLL) and acute myeloid leukemia.

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This approval is based on the submitted clinical study report M12-175, which involved two patient groups: Group A, which included patients with CLL / LML, and Group B, which included patients with non-Hodgkin's lymphoma (NHL). In addition, as a justification for the amendment, clinical recommendations "Chronic lymphocytic leukemia / lymphoma from small lymphocytes", 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 / lymphoma from small lymphocytes "approved in the USA2. In addition, the indications for CLL and LML are also approved in the USPI.

''More than 19.3 million new cases of malignant diseases are registered in the world every year. In 2020, over 474 thousand new cases of leukemia and more than 311 thousand deaths from leukemia were recorded, - comments Dmitry Koloda, Medical Director of AbbVie in Russia and the CIS. “We see our mission in expanding the experience in the treatment of various types of hematological cancers in order to save the lives of thousands of patients. Therefore, the approval of a new indication of the drug is an important step on this path, and we do not intend to stop and only move forward to expand the company's oncological portfolio. "

For LML therapy, as well as for CLL therapy, the following venetoclax release forms are available in Russia: film-coated tablets, 10 mg, 50 mg and 100 mg.

Source from Remedium