SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a part of the Roche Group (RHHBY.PK), on Wednesday said the U.S. Food and Drug Administration approved a supplemental biologics license application for Gazyva in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia, one of the most common forms of blood cancer.
According to Genentech, the supplemental biologics license application (sBLA) adds to the label data from Stage 2 of the CLL11 study showing significant improvements with Gazyva plus chlorambucil across multiple clinical endpoints whencompared head-to-head with Rituxan (rituximab) plus chlorambucil.
The approval includes complete response (CR) and minimal residual disease data from Stage 2 of the study. Additionally, overall survival data was added from Stage 1 of the study comparing Gazyva plus chlorambucil to chlorambucil alone.
The sBLA approval updated the Gazyva prescribing information with the following data
- Gazyva plus chlorambucil helped people with previously untreated chronic lymphocytic leukemia (CLL) live nearly a year longer without their disease worsening or death (progression-free survival; PFS) than Rituxan plus chlorambucil (median PFS: 26.7 months vs. 14.9 months, respectively).
- Gazyva plus chlorambucil nearly tripled the number of people showing no evidence of disease (CR) compared to Rituxan plus chlorambucil (26.1 percent vs. 8.8 percent, respectively).
- Of the people who achieved a complete response with or without complete recovery from abnormal blood cell counts, 19 percent of people in the Gazyva arm compared to 6 percent of people in the Rituxan arm were MRD negative in the bone marrow, and 41 percent of people in the Gazyva arm compared to 12 percent people in the Rituxan arm were MRD negative in the peripheral blood. MRD negative means no residual traces of the cancer were found.
- Data from the first stage of the CLL11 study showed that at nearly two years, the rate of death was 9 percent for people who received Gazyva plus chlorambucil compared to 20 percent for those who received chlorambucil alone.
The most common side effects of Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.
Gazyva can cause serious or life-threatening side effects including: Hepatitis B reactivation, progressive multifocal leukoencephalopathy, infusion reactions, tumor lysis syndrome, infections, and low white blood cell counts.
Gazyva, the first medicine approved with the FDA's Breakthrough Therapy Designation, was approved for use in combination with chlorambucil in people with previously untreated CLL in November 2013. Gazyva, known as Gazyvaro in Europe, was approved by the European Commission for the same indication in July 2014.
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body's immune system. In the United States, Gazyva is part of a collaboration between Genentech and Biogen Idec.
The drug is also being investigated in a broad development program across various types of blood cancers, including multiple Phase III studies in non-Hodgkin's lymphoma.
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