FDA approves Gazyva for CLL

The FDA today granted approval of obinutuzumab in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukemia.

Obinutuzumab (Gazyva, Genentech) — a glycoengineered, humanized, monoclonal antibody — is indicated for use with chlorambucil (Leukeran, Aspen Global).

The FDA based its approval in part on results of an open-label, multicenter study that included 356 patients with previously untreated CLL. They received obinutuzumab in combination with chlorambucil or chlorambucil alone.

Patients assigned to the combination therapy demonstrated significantly improved PFS compared with those who received chlorambucil alone (23 months vs. 11.1 months).

The most common side effects associated with obinutuzumab were infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain and pyrexia.

Obinutuzumab will contain a boxed warning alerting patients of the risks for Hepatitis B and progressive multifocal leukoencephalopathy, both of which are known risks associated with other monoclonal antibodies in the same class.

Obinutuzumab was approved under the FDA priority review program. It is the first drug designated as a breakthrough therapy to receive FDA approval.

Richard Pazdur

“Today’s approval represents an important new addition to the treatments for patients with CLL,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”