FDA approves new Novartis drug for multiple myeloma

MarketsAssociated Press

Federal health officials have approved a new drug from Swiss drugmaker Novartis to treat a form of bone marrow cancer.

The Food and Drug Administration said Monday it approved Farydak for patients with multiple myeloma, which causes the buildup of plasma cells in the bone marrow. The cells can spread to other parts of the body, weakening the immune system and causing conditions like anemia.

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About 10,700 U.S. patients die of the disease each year, according to the National Cancer Institute.

Farydak works by blocking enzymes that are thought to drive the overproduction of cells. The drug is approved for patients who have already tried at least two older drugs, including the chemotherapy bortezomib.

An advisory committee of FDA experts voted against Farydak for a broader population of patients in November. However, after the meeting Novartis submitted additional information on the drug's use in patients who had already tried two other treatments.

Company studies showed patients taking Farydak lived nearly 5 months longer without their cancer spreading than patients taking a combination of older drugs.

The drug will carry a boxed warning label about side effects including diarrhea and heart problems.

Novartis is based in Basel, Switzerland.