Roche's Gazyva gains FDA approval of CLL

The US Food and Drug Administration late Friday approved Swiss drug major Roche’s (ROG: SIX) Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL), making it the first to be approved as first-line therapy for this condition.

Gazyva is the first medicine approved under the FDA’s Breakthrough Therapy Designation system, and the fifth cancer medicine from Roche cleared by the FDA in the past three years, the company noted. Gazyva has demonstrated an 84% reduction in the risk of disease worsening or death when combined with chemotherapy compared to chemotherapy alone.

Roche noted that Gazyva is part of a collaboration between its US subsidiary Genentech and Biogen Idec (Nasdaq: BIIB) in the USA. Genentech said that Gazyva will be available to people in the USA within around two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Gazyva through Genentech Access Solutions.