- NHL Treatment
- Hodgkin's Treatment
- Clinical Trials
- Monoclonal Antibodies
The U.S. Food and Drug Administration has approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). The drug works by helping certain cells in the immune system attack cancer cells.
Gazyva becomes the first drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence demonstrates that the drug in question may offer a significant improvement over available therapies for patients facing serious or life-threatening diseases.
Gazyva also enjoyed orphan drug status and was granted priority review.
In a statement, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said:
Today’s approval represents an important new addition to the treatments for patients with CLL. This approval reflects the promise of the Breakthrough Therapy Designation program, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs.
Gazyva will come with a boxed warning regarding Hepatitis B virus reactivation and a rare disorder known as progressive multifocal leukoencephalopathy (PML), which damages the material that covers and protects nerves in the white matter of the brain. These are known risks with other monoclonal antibodies in this class (such as Rituxan), and rare cases were identified in participants on other trials of Gazyva. Patients should be advised of these risks and assessed for Hepatitis B virus and reactivation risk.