AbbVie and Genentech’s Chemotherapy-Free Combination Therapy Receives FDA Approval for First-Line Treatment of Chronic Lymphocytic Leukemia

VCBeat (WeChat Official Account: vcbeat) has learned that on May 15, AbbVie announced that the combination therapy of Venclexta (venetoclax) and Gazyva (obinutuzumab), co-developed with Genentech, a member of the Roche Group, has received FDA approval for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This regimen is the first chemotherapy-free combination therapy approved by the FDA for patients receiving initial treatment for CLL and SLL. Genentech will be responsible for advancing the commercialization of Venclexta in the United States, while AbbVie will lead its commercialization in regions outside the United States.

AbbVie is a research-based global biopharmaceutical company established in 2013 following its separation from Abbott. The company’s mission is to develop and advance innovative therapies that address some of the world’s most serious and complex diseases, leveraging its expertise, dedicated people, and unique approach to innovation. To date, AbbVie employs approximately 21,000 people worldwide and operates in more than 170 countries.

Genentech, a biotechnology company, was founded in San Francisco, California, in 1976 with the aim of developing, manufacturing, and commercializing therapeutic drugs for serious diseases. After being acquired by Roche in 2009, Genentech’s research and early development division continued to operate as an independent center within Roche, and its campus in South San Francisco became the U.S. headquarters of Roche’s pharmaceutical business.

Chronic lymphocytic leukemia (CLL) is a chronic cancer of the bone marrow and blood, typically caused by B lymphocytes that have become cancerous and proliferate abnormally. In the United States, there are more than 20,000 newly diagnosed cases of leukemia each year. The process by which cells naturally die or self-destruct is known as apoptosis. In certain hematologic malignancies, the B-cell lymphoma-2 (BCL-2) protein can prevent cancer cells from undergoing apoptosis.

Gazyva is generally administered after patients receive the chemotherapy drug bendamustine and is indicated for those who have not responded to rituximab (Rituxan) therapy or whose lymphoma has relapsed following treatment. As an engineered monoclonal antibody, Gazyva targets a protein called CD20, which is typically found on certain types of B cells. This medication works by directly attacking the targeted cells as well as by harnessing the body’s own immune system.

Venclexta, approved this time, is an oral B-cell lymphoma-2 (BCL-2) inhibitor that selectively binds to and inhibits the BCL-2 protein, restoring the apoptosis process. In a multicenter, randomized Phase 3 CLL14 trial conducted in collaboration with the German CLL Study Group (DCLLSG), the efficacy of VENCLEXTA in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) was confirmed.

VENCLEXTA has received five Breakthrough Therapy Designations from the FDA. In April 2016, VENCLEXTA received its initial FDA approval for the treatment of patients with chronic lymphocytic leukemia (CLL) with deletion 17p who had received at least one prior therapy. In June 2018, VENCLEXTA received its second approval for the treatment of patients with CLL or small lymphocytic lymphoma (SLL), with or without deletion 17p, who had received at least one prior therapy. In November 2018, the FDA approved the combination of VENCLEXTA with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older.

Venetoclax has received marketing approval in more than 50 countries. Currently, AbbVie and Genentech are investigating the use of Venetoclax in several other hematologic malignancies, including acute myeloid leukemia (AML), multiple myeloma (MM), non-Hodgkin lymphoma (NHL), and myelodysplastic syndromes (MDS).

Sandra Horning, Chief Medical Officer at Genentech, said, “Compared with standard treatment, the combination of Venclexta and Gazyva is the only chemotherapy-free regimen. Our mission is to help patients with blood cancers throughout the course of their disease. We are pleased to offer this new option for patients with previously untreated chronic lymphocytic leukemia.”

Dr. Michael Severino, Vice Chairman and President of AbbVie, stated, “This approval is based on the results of the CLL14 trial. Within two years following up to one year of treatment, the disease did not progress in most patients.”

(Compiled by Li Chengping)