US nod for Venclexta/Rituxan combo

The decision allows doctors to prescribe the drug - irrespective of the presence of the 17p deletion – for patients who have received at least one prior line of therapy.

Earlier this year the New England Journal of Medicine published data from the Phase III Murano trial, which showed that after a median follow-up period of 23.8 months, progression-free survival was significantly higher in patients taking the Venclexta (venetoclax)/Rituxan (rituximab) combination (with 32 events of progression or death in 194 patients) than in the bendamustine–rituximab group (114 events in 195 patients).

Also, the two-year rates of progression-free survival were 84.9 percent and 36.3 percent, respectively, according to the results.

"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," noted Sandra Horning, chief medical officer and head of Global Product Development at Roche.

The US Food and Drug Administration initially cleared Venclexta last year for use in the second-line setting to treat CLL patients carrying the 17p deletion chromosomal abnormality.

However, the regulator has now also converted the accelerated approval for the agent as a standalone therapy to a full clearance, widening its scope to include all CLL or SLL patients in the second-line setting, regardless of the presence of the 17p mutation.

-----------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.