Roche-AbbVie cancer drug gets accelerated FDA approval

Roche Holding said its cancer drug, Venclexta, received accelerated approval from the US Food and Drug Administration as part of a combination treatment for newly diagnosed patients with a form of leukemia.

The drug, developed in partnership with AbbVie, was approved for patients with acute myeloid leukemia (AML) aged 75 or older, or those ineligible for intensive induction chemotherapy.

"Many people with acute myeloid leukemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients," said Sandra Horning, Chief Medical Officer, Genentech, a unit of Roche.

Venclexta has been previously approved for forms of chronic lymphocytic leukemia, and a late-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 the aggressive blood cancer in adults, has the lowest survival rate for all types of leukemia, the company said. The American Cancer Society estimates about 19,520 new cases of the cancer in the US this year.