FDA approves 'breakthrough therapy' for CLL

FDA Approves Gazyva for Chronic Lymphocytic Leukemia
FDA Approves Gazyva for Chronic Lymphocytic Leukemia

HealthDay News -- The FDA has approved obinutuzumab (Gazyva) for use in combination with the anti-cancer drug chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL).

The drug, which is designed to bolster the immune system's ability to attack cancer cells, was granted so-called "breakthrough therapy" status, because it "may offer a substantial improvement over available therapies," the agency said in a press release.

Obinutuzumab, a third-generation type II anti-CD20 antibody, underwent priority review and was given orphan drug status because of how rare CLL is. Some 15,680 Americans are likely to be diagnosed and 4,580 are projected to die from CLL this year, the U.S. National Cancer Institute estimates.

The approval was based on clinical studies involving 356 patients. Those receiving the obinutuzumab/chlorambucil combination had an average of 23 months of progression-free survival compared with 11.1 months among participants who received chlorambucil alone, the FDA said.

The most common side effects include infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain and fever.

The obinutuzumab label contains a boxed warning that it could trigger a "reactivation" of the hepatitis B virus, and it may increase users' risk of a rare neurological disorder called progressive multifocal leukoencephalopathy.

The drug is marketed by Genentech.

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