FDA Approves Obinutuzumab (Gazyva) for CLL
The US Food and Drug Administration (FDA) has approved obinutuzumab (Gazyva, Genentech) for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
The drug is indicated for use in combination with chlorambucil in this setting.
Obinutuzumab is a glycoengineered antibody, which means that specific sugar molecules in GA101 were modified to change its interaction with immune cells.
"Today's approval represents an important new addition to the treatments for patients with CLL," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, in a press statement.
Obinutuzumab is the first drug with a "breakthrough therapy" designation to receive FDA approval. That means that obinutuzumab has the potential to offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
"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," said Dr. Pazdur.
In the pivotal phase 3 CLL11 trial, patients with previously untreated CLL who received obinutuzumab in combination with chlorambucil had significantly better median progression-free survival than those treated with chlorambucil alone (23.0 vs 11.1 months).
The 356-patient study was a randomized open-label multicenter trial.
The most common adverse effects in participants receiving obinutuzumab were infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and pyrexia, according to the FDA.
Obinutuzumab is being approved with a boxed warning about hepatitis B virus reactivation. Patients should be assessed for hepatitis B virus and their related reactivation risk. The boxed warning includes another concern: the drug's risk of inducing progressive multifocal leukoencephalopathy.
According to the FDA, these are known risks with other monoclonal antibodies in this class, and rare cases have been identified in participants in other trials of obinutuzumab.