ZURICH (Reuters) – Roche Holding AG’s Venclexta has won breakthrough therapy designation in acute myeloid leukaemia (AML) from the U.S. Food and Drug Administration, the Swiss drugmaker said on Friday.
The designation covers Venclexta in combination with low dose cytarabine for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy, it said.
Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Roche unit Genentech in the United States and by AbbVie elsewhere.
Reporting by Michael Shields