On January 29, 2020 AbbVie (NYSE: ABBV ), a global biopharmaceutical company based on research and development, reported the approval by the regulatory agency ANVISA of VENCLEXTA (venetoclax), in combination with obinutuzumab, for treating patients with CLL without prior treatment (Press release, AbbVie, JAN 29, 2020, View Source [SID1234553673]). 1 The combination was considered "Revolutionary Treatment" by the FDA.

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"This approval by ANVISA is a new option of therapeutic combination without chemotherapy and highlights the growing use of venetoclax for the treatment of LLC", said Karina Fontão, Medical Director of AbbVie in Brazil. "The approval was based on the results of the CLL study 14 , in which patients received treatment for 12 months. Most patients treated with venetoclax in the study did not show disease progression in an evaluation carried out two years after treatment."

CLL 14 data were presented at the EHA (Free EHA Whitepaper) (Congress of the European Association of Hematologists) 2019.

"Patients with CLL have been undergoing chemotherapy as an initial treatment," said physician Michael Hallek, principal investigator in the CLL 14 study and head of the Department of Internal Medicine and Center for Integrated Oncology at the University Hospital in Cologne, Germany. "This approval allows patients with CLL, who have not yet received treatment, to start with a fixed-term treatment, without the use of chemotherapy, which can allow them to live longer, without progression of the disease, with minimal undetectable residual disease (undetectable disease in the blood) or bone marrow) and, more importantly, allows them to complete their course of treatment in 12 months. "

The CLL 14 study demonstrated higher progression-free survival rates (period from the start of treatment to the progression of the disease or death), assessed by an independent review committee, in patients treated with the combination of VENCLEXTA and obinutuzumab compared to patients who received the combination chlorambucil and obinutuzumab, one of the commonly used treatments. With an average follow-up of 28 months (range 0.1 to 36 months), the combination with VENCLEXTA reduced the risk of progression or death in 67% of patients, compared with the combination of chlorambucil with obinutuzumab. The minimal residual disease rate was assessed as a secondary study outcome and is defined as the presence of less than one LLC cell detected in 10,000 leukocytes, using sensitive analytical methods.2 .

In the CLL 14 study, adverse events were compatible with the known safety profile of VENCLEXTA and obinutuzumab used alone.

VENCLEXTA, a BCL-2 protein inhibitor, received five Revolutionary Therapy designations from the FDA. 3,4,5,6,7

VENCLEXTA is approved in more than 50 countries, including the United States and Brazil.

In Brazil, VENCLEXTA is also approved for the treatment of relapsed / refractory LLC and acute myeloid leukemia (AML). 1

About Chronic Lymphocytic Leukemia

LLC is a slow-progressing cancer in the blood and bone marrow in which some white blood cells called B lymphocytes become cancerous and multiply abnormally. 7 In the United States, LLC adds more than 20,000 new cases each year. 8 In Brazil, according to information from INCA 2018, there are 10,800 new cases of leukemia in the year. 8

About VENCLEXTA (venetoclax)

VENCLEXTA is the first in a new class of drugs that selectively inhibits the BCL-2 protein. In some types of blood cancer and other tumors, BCL-2 prevents the natural process of cancer cell death, or a process of self-destruction called apoptosis. VENCLEXTA targets the BCL-2 protein and acts to restore the apoptosis process 1 and is also being evaluated for the treatment of patients with several other types of cancer.

VENCLEXTA is developed by AbbVie and Roche, being marketed jointly by AbbVie and Genetench, a Roche group company, in the United States, and by AbbVie, outside the United States. Together, the companies are committed to researching BCL-2 and evaluating VENCLEXTA in clinical studies for various types of blood cancer and other tumors.