FDA Approves Farydak (Panobinostat) for Multiple Myeloma

The US Food and Drug Administration (FDA) has approved Farydak (panobinostat) for people with multiple myeloma. Farydak is an HDAC inhibitor, the first drug of this type to be approved for multiple myeloma. It works by blocking certain enzymes that help cancer cells grow and stay alive.

Farydak is meant only for people who have already received at least 2 other treatments, including the chemotherapy drug Velcade (bortezomib) and an immunotherapy drug. Last November, an FDA advisory committee voted against approving Farydak for people with multiple myeloma that came back after treatment because it was felt the benefits did not outweigh the risks. But since then, Novartis, the company that makes the drug, has submitted new information for its use in people who have already tried at least 2 other options.

The new approval is based on a study of 193 people with multiple myeloma who had previously received at least 2 treatments, including Velcade and an immunotherapy drug. In the study, people were randomly assigned to receive a combination of Farydak, Velcade, and dexamethasone, or only Velcade and dexamethasone.

Results showed that those who received Farydak lived for an average 10.6 months without their cancer getting worse compared to 5.8 months for those who did not receive Farydak. In addition, 59% of people who received Farydak had their cancer shrink or disappear compared to 41% of people who did not receive Farydak.

Farydak was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

Farydak is taken by mouth and is given along with Velcade (bortezomib) and dexamethasone, an anti-inflammatory medicine. The drug carries a boxed warning, which is the FDA’s strictest warning for drugs that have serious side effects. They include severe diarrhea and serious heart problems.

The most common side effects are less severe and included diarrhea, tiredness, nausea, vomiting, swelling in the arms or legs, decreased appetite, fever, and weakness.

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