AbbVie and Roche’s Venclexta and Rituxan Combo Gets FDA Approval

FDA Approval

The U.S. Food and Drug Administration (FDA) approved AbbVie and Roche’s combination of Venclexta in combination with Rituxan (rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion in patients who have received at least one previous therapy.

The approval was built on the MURANO Phase III clinical trial. In the trial, patients who received Venclexta plus Rituxan had significantly improved progression-free survival (PFS) for relapsed/refractory CLL, cutting the risk of disease progression or death by 81 percent compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy. Patients receiving the combination also had an overall response rate (ORR) of 92 percent compared to 72 percent in patients who received the bendamustine plus rituximab combination.

“Venclexta now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care,” said Michael Severino, AbbVie’s executive vice president, research and development, and chief scientific officer, in a statement. “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. 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.”

In 2016, the FDA approved Venclexta as a second-line treatment for CLL patients who have a 17p deletion—that is to say, a piece of the top part of chromosome 17 is missing. This new data and approval give physicians the go-ahead to use the drug combo in patients who don’t have that mutation as well, both alone and in combination with Rituxan.

It is also being reviewed by the European Medicines Agency.

According to EvaluatePharma, Venclexta is projected to bring in $2.5 billion in 2024. Roche’s Genentech and AbbVie collaborate on Venclexta development. The two companies also co-market the drug in the U.S., while AbbVie has the rights to sell it everywhere else in the world. Geoffrey Porges, an analyst with Leerink, predicts the combination will hit $590 million in 2019.

The two companies are also evaluating the drug for acute myeloid leukemia (AML) and some subpopulations of multiple myeloma patients. Venclexta is also being studied in combination with AbbVie’s Imbruvica (ibrutinib).

Roche’s chief medical officer, Sandra Horning, said in a statement, “We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukemia whose disease has returned after previous treatment. Venclexta plus Rituxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy.”

Venclexta is an oral BCL-2 inhibitor. BCL-2 is shown to build up in patients with CLL or SLL, which prevents cancer cells from self-destructing naturally. Rituxan targets and attaches to the CD20 protein found on the surface of blood cells with cancer and some healthy blood cells.

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