AbbVie and Roche’s Venclexta Plus Gazyva Approved by FDA as First-Line Chemotherapy-Free Regimen for CLL, Reducing Risk of Progression or Death by 67%

Today, AbbVie announced that Venclexta (venetoclax), a blockbuster anticancer drug co-developed with Roche, has received FDA approval for use in combination with Gazyva (obinutuzumab) as a first-line treatment for patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is a chemotherapy-free combination regimen. The FDA evaluated the supplemental new drug application through its Real-Time Oncology Review (RTOR) program, granting approval just two months after accepting the application.

CLL typically originates in the blood and bone marrow, characterized by the gradual accumulation of excessive abnormal lymphocytes. It is one of the most common types of leukemia in adults. In 2018, there were approximately 20,000 new cases of CLL in the United States. Although symptoms of CLL may disappear after treatment, cancer cells often recur, necessitating long-term additional therapy for patients. Therefore, patients require improved therapies to help extend their progression-free survival (PFS) and minimize the risk of disease recurrence.

Venetoclax is a highly specific BCL-2 inhibitor and the first FDA-approved therapy targeting BCL-2. BCL-2 plays a critical role in the process of apoptosis. By inhibiting the function of BCL-2, Venetoclax can restore the apoptotic process in cancer cells. Obinutuzumab targets the CD20 antigen expressed on the surface of specific B cells; it can directly attack malignant B cells or exert anticancer effects by modulating the body’s immune system. The FDA has previously granted this combination therapyBreakthrough Therapy Designation, for the treatment of previously untreated CLL/SLL patients.

This approval is based on the performance of the combination therapy in the Phase 3 clinical trial CLL14. The trial results demonstrated that, compared with the standard therapy consisting of the chemotherapy drug chlorambucil and obinutuzumab, the combination of venetoclax and obinutuzumab significantly improved patients’ progression-free survival. Compared with the standard therapy, this combination reduced the risk of disease progression or death by 67% (HR: 0.33; 95% CI: 0.22, 0.51; p<0.0001). Treatment was completed within 12 months, and 87% of patients remained free from disease progression during the 28-month follow-up period.

“The FDA’s approval of this chemotherapy-free combination regimen underscores the growing potential of Venclexta in treating patients with CLL,” said Dr. Michael Serverino, Vice Chairman and President of AbbVie Inc. “In the CLL14 clinical trial, patients received a 12-month course of treatment, and the majority remained progression-free at two years.”

References:

[1] AbbVie Announces US FDA Approval of VENCLEXTA® (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients. Retrieved May 15, 2019, from https://news.abbvie.com/news/press-releases/abbvie-announces-us-fda-approval-venclexta-venetoclax-as-chemotherapy-free-combination-regimen-for-previously-untreated-chronic-lymphocytic-leukemia-patients.htm

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