AbbVie and Roche get win on first chemo-free oral combination treatment.

Chronic lymphocytic leukemia (CLL) is an incurable disease in which cancerous cells form in the blood and bone marrow. Small lymphocytic lymphoma (SLL) is similar but occurs in the lymph nodes. CLL is the most common type of leukemia developed by adults, with approximately 20,000 new cases diagnosed in the US alone each year. Although for many patients initial treatment can provide positive results, the disease returns in most cases and additional treatment is required. 

For those patients with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy, the FDA recently approved  a new treatment option) from Genentech, a member of the Roche Group, and Abbvie: Venclexta® (venetoclax) and Rituxan® (rituximab). The two companies are jointly commercializing the new treatment within the US, and AbbVie is responsible for its commercialization in the rest of the world. 

Venclexta is a small-molecule drug designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in apoptosis (programmed cell death). Overexpression of the BCL-2 protein in CLL has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct.

FDA’s approval was based on the results of the phase 3 MURANO clinical trial. A fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 81% compared with bendamustine plus Rituxan, a current standard of care. 

Venclexta was previously granted accelerated approval in April 2016 as a single agent for the treatment of people with CLL with 17p deletion, who have received at least one prior therapy. This new FDA decision converts that accelerated approval into a full approval. The Venclexta/Rituxan combination treatment is also the first chemo-free oral combination with a fixed treatment duration for CLL. 

Different analysts predict sales for the Venclexta/Rituxan combination treatment of $690 million in 2019, with peak sales eventually reaching approximately $3 billion.