US FDA approves Genentech’s rare disease drug for CLL

The US Food and Drug Administration has approved Genentech’s chronic lymphocytic leukemia drug Gazyva. It is the first drug with breakthrough therapy designation to receive FDA approval. It has also received orphan product designation, because it is intended to treat a rare disease.

Gazyva (obinutuzumab) has been approved for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL), which is a bone and blood marrow disease.

“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.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Gazvya’s approval for CLL was based on a clinical trial of 356 patients which compared Gazyva in combination with chlorambucil to chlorambucil alone in participants with previously untreated CLL. Participants receiving Gazyva in combination with chlorambucil demonstrated a significant improvement in progression free survival: an average of 23 months compared with 11.1 months with chlorambucil alone.

“Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as it more than doubled the time people lived without their disease worsening compared to chlorambucil alone. We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers.”

Hal Barron, M.D., chief medical officer and head of Global Product Development, Genentech.

Final clinical trial data will be presented at the American Society of Hematology’s (ASH) 55th Annual Meeting in December 2013. Genentech, which is a member of the Roche Group has also submitted marketing applications to other regulatory authorities, including the European Medicines Agency (EMA).


Reference links:

FDA press release

Genentech press release

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