Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Friday that that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with biopharmaceutical company AstraZeneca's (STO:AZN) (LON:AZN) (NYSE:AZN) Calquence (acalabrutinib) for previously untreated adults with chronic lymphocytic leukaemia (CLL), based on Phase III AMPLIFY data.

The all-oral, fixed-duration regimen expands Genentech's first-line fixed-duration portfolio alongside Venclexta plus Gazyva (obinutuzumab), offering eligible patients potential time off treatment.

In AMPLIFY, Venclexta plus acalabrutinib reduced the risk of disease progression or death by 35% versus chemoimmunotherapy, with median progression-free survival not reached at 42.6 months versus 47.6 months for chemoimmunotherapy. The safety profile was consistent with known effects of each therapy; common adverse reactions included neutropenia, headache, diarrhoea, musculoskeletal pain, and COVID-19, while serious events included COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%).

Chronic lymphocytic leukaemia remains among the most common adult leukaemias, with patients often requiring prolonged treatment and ongoing disease management.