FDA Approves Darzalex (Daratumumab) for Multiple Myeloma

The US Food and Drug Administration (FDA) has approved the first monoclonal antibody to treat people with multiple myeloma, a type of cancer that starts in plasma cells. A monoclonal antibody is a type of immunotherapy drug that works by helping the body’s own immune system find and destroy cancer cells. Darzalex (daratumumab) is for people with multiple myeloma who have tried at least 3 other drug treatments.

The FDA based its approval on 2 studies. In the first study, 106 people were given Darzalex and 29% saw a reduction in the amount of cancer in their bodies, which lasted for an average 7.4 months. In the second study, 42 people were given Darzalex and 36% saw a reduction of in the amount of cancer in their bodies.

Darzalex was approved using several FDA approaches designed to speed up the availability of drugs to treat serious diseases – breakthrough therapy designation, priority review, and accelerated approval. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

Darzalex is given as an infusion into a vein. The most common side effects are infusion reactions, fatigue, nausea, back pain, fever, and cough. Darzalex may also result in low levels of red blood cells (anemia), white blood cells (increasing the risk of infections) and platelets (increasing the risk of bleeding).

The drug may interfere with certain tests done by blood banks for people who need a blood transfusion. Women should not take Darzalex while pregnant, and should not become pregnant within 3 months after taking the drug.

Darzalex is marketed by Janssen Biotech.

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