Roche-AbbVie cancer drug, Venclexta gets accelerated FDA approval
New Delhi: Roche Holding AG said on Wednesday its cancer drug, Venclexta, received accelerated approval from the U.S. Food and Drug Administration as part of a combination treatment for newly diagnosed patients with a form of leukaemia.
The drug, developed in partnership with AbbVie Inc, was approved for patients with acute myeloid leukaemia (AML) aged 75 or older, or those ineligible for intensive induction chemotherapy.
"Many people with acute myeloid leukaemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients," said Sandra Horning, the chief medical officer at Genentech, a unit of Roche.
Venclexta has been previously approved for forms of chronic lymphocytic leukaemia, and a mid-stage study recently showed that it helped reduce the risk of disease worsening when used with Roche's cancer drug Gazyva.
AML, the most common type of aggressive blood cancer in adults, has the lowest survival rate for all types of leukaemia, the company said. The American Cancer Society estimates about 19,520 new cases of cancer in the United States this year.