AbbVie Announces USFDA Approval of VENCLEXTA in Combination with Rituximab

AbbVie, a research-based global biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. The approval is based on MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival (PFS) for relapsed/refractory (R/R) CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen.

Clinical trial patients who received VENCLEXTA plus rituximab also achieved an overall response rate (ORR) of 92 percent and those who received the chemoimmunotherapy regimen achieved an ORR of 72 percent.  The safety profile of the combination is consistent with the known safety profile of VENCLEXTA. The most common adverse reactions (ARs), greater than or equal to 20 percent, with VENCLEXTA in combination with rituximab were neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough and nausea. VENCLEXTA plus rituximab is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration.

“VENCLEXTA now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care. This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment allowing patients the ability to stop treatment after approximately two years,” said Michael Severino, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. “This is an important step for patients and we look forward to continuing to provide new treatment options for people living with difficult-to-treat blood cancers.”

VENCLEXTA has been granted four Breakthrough Therapy Designations (BTDs) from the FDA including for the combination treatment regimen of VENCLEXTA plus rituximab for patients with R/R CLL.² The approval of the VENCLEXTA plus rituximab treatment regimen marks the second approval granted under priority review by the FDA for VENCLEXTA. Outside of the US, regulatory submissions to and reviews with health authorities are underway. “The approval of the combination of VENCLEXTA plus rituximab for patients with relapsed/refractory CLL or SLL validates the results seen in the Phase 3 trial, including the significant improvement in progression-free survival over a standard of care comparator arm,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO study and Director of Cancer Medicine at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Australia. “Progression-free survival is considered a gold standard for demonstrating clinical benefit in oncology.”

CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called lymphocytes become cancerous and multiply abnormally. In the US, CLL accounts for more than 20,000 newly diagnosed cases of leukemia each year.  SLL is closely related to CLL. However, unlike CLL, SLL cancer cells are typically found in the lymph nodes and spleen rather than the bone marrow and the blood. In the US, approximately 5000 cases of SLL are diagnosed annually. The FDA has also approved expansion of the indication of VENCLEXTA as monotherapy for CLL or SLL patients, with or without 17p deletion, who have received one prior therapy. Previously, VENCLEXTA, the first B-cell lymphoma-2 (BCL-2) inhibitor in CLL, was approved under accelerated approval in the US in April 2016 as a monotherapy for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. VENCLEXTA is being developed by AbbVie and Roche; it is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US. – Medical Buyer Bureau