AbbVie, Roche post a big win with a blockbuster FDA OK for Venclexta/Rituxan combo for leukemia

Roche’s oncology team has posted another regulatory win.

Sandra Horning

The pharma giant — allied with AbbVie — says the FDA has approved a combination of Venclexta and Rituxan as a second-line therapy for chronic lymphocytic leukemia or small lymphocytic lymphoma. This is the first chemo-free oral combination with a fixed treatment duration for CLL.

AbbVie and Roche are partnered on Venclexta.

The approval is based on the stellar data garnered in their Phase III MURANO study, in which the combo sparked an 81% reduction in the risk of death or disease progression compared to Rituxan and chemo. In the trial, the 24-month PFS rate hit 84.9% for the AbbVie $ABBV/Roche $RHHBY combo against 36.3% for chemo/Rituxan. And the complete response rate — no sign of the disease — registered at 26.8% against 8.2%.

Geoffrey Porges believes that the combo is headed to $690 million in 2019 sales, with Evaluate pegging consensus peak estimates at around $3 billion.

“We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukaemia whose disease has returned after previous treatment,” said Roche CMO Sandra Horning in a statement. “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.”

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Sr. Manager, Regulatory Affairs, CMC
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