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Bloomberg Businessweek – Roche Wins U.S. Approval for First Breakthrough Therapy Drug

Bloomberg Businessweek – Roche Wins U.S. Approval for First Breakthrough Therapy Drug

Roche Holding AG (ROG) won approval for its Gazyva drug for patients with leukemia who haven’t been treated before.

The medicine, also known as obinutuzumab, is cleared to treat chronic lymphocytic leukemia and is the first breakthrough therapy ever to receive approval, the Food and Drug Administration said today in a statement. The FDA granted Gazyva the designation, which means preliminary evidence indicated it might offer substantial improvement over current treatment.

CLL is a blood and bone marrow disease that typically worsens slowly, the FDA said. About 15,680 Americans will be diagnosed with the disease and 4,580 will die from it this year. Gazyva is approved for use in combination with chlorambucil, another drug for 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, director of the Office of Hematology and Oncology Products at the FDA, said in the statement.

Congress gave the FDA the authority to designate breakthrough therapies last year, allowing the agency to work more closely with drugmakers whose medicines are particularly promising to usher the products to market. The FDA wasn’t expected to decide on Gazyva until Dec. 20.

Boxed Warning

The drug will carry a boxed warning regarding hepatitis B reactivation and a rare nerve disorder in the brain, the FDA said.

“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,” said Hal Barron, chief medical officer and head of Global Product Development at Basel, Switzerland-based Roche’s Genentech unit, in a statement.

In a clinical trial of 356 patients, those taking Gazyva and chlorambucil lived without the disease progressing an average of 23 months compared with 11 months for those who took chlorambucil alone.