FDAnews Drug Daily Bulletin

Roche’s Gazyvaro for Chronic Lymphocytic Leukemia Gets EU Nod

Aug. 5, 2014

European regulators have approved Roche’s Gazyvaro in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL) patients who are unable to tolerate more intensive therapies.

The EU authorization was based on a Phase III open-label, multicenter study in which Gazyvaro (obinutuzumab) with chlorambucil cut patients’ risk of disease progression and death by 61 percent when compared with MabThera/Rituxan plus chlorambucil. Patients receiving Gazyvaro had median progression-free survival of 26.7 months — 11.5 months longer than patients receiving the comparator drug cocktail.

Gazyvaro helps patients achieve a deep response to treatment, which translates into longer lasting remissions, said Sandra Horning, Roche’s chief medical officer and head of global product development.

Roche said that it expects to launch the drug in Europe this year.

The FDA approved obinutuzumab — known as Gazyva in the U.S. — last fall as the first product under its breakthrough therapy designation.

Gazyvaro’s European clearance comes on the heels of other CLL drug approvals in the U.S., including the FDA’s approval of Janssen and Pharmacyclics’ Imbruvica (ibrutinib) for CLL patients who have a 17p chromosome deletion, and the agency’s July 23 approval of Gilead’s Zydelig (idelalisib) for use in combination with Genentech’s Rituxan (rituximab) — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.