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November 16, 2015

Janssen Biotech’s Darzalex drug gets FDA approval to treat multiple myeloma

Janssen Biotech has received approval from the US Food and Drug Administration (FDA) for Darzalex (daratumumab) to treat multiple myeloma (MM) patients who have received at least three prior lines of therapy.

Darzalex

Janssen Biotech has received approval from the US Food and Drug Administration (FDA) for Darzalex (daratumumab) to treat multiple myeloma (MM) patients who have received at least three prior lines of therapy.

Darzalex is the first human anti-CD 38 monoclonal antibody designed to help certain cells in the immune system fight cancer cells.

The drug is believed to induce tumour cell death through apoptosis. This process involves a series of molecular steps in a cell that lead to its death and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

During clinical studies involving over 140 people, Darzalex was found to reduce the cancer’s spread by 29% to 36%.

"We will continue to study this compound as both a mono and a combination therapy to understand its full clinical benefit for patients across the treatment continuum in multiple myeloma and other tumour types."

The drug’s most common side-effects were infusion-related reactions, fatigue, nausea, back pain, fever and cough. It could also reduce white blood cells, red blood cells and blood platelets.

Janssen global oncology head Peter Lebowitz said: "We will continue to study this compound as both a mono and a combination therapy to understand its full clinical benefit for patients across the treatment continuum in multiple myeloma and other tumour types."

The recommended dose of Darzalex is 16mg/kg body weight and is administered as an intravenous infusion.

The dosing schedule begins with weekly administration for first eight weeks and reduces in frequency over time to every two weeks from nine to 24. It should be administered for every four weeks from week 25 onwards until disease progression.

Janssen licensed Darzalex from Genmab under a worldwide agreement reached in August 2012.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells found in the bone marrow.


Image: Darzalex is believed to induce tumour cell death through apoptosis. Photo: courtesy of Johnson & Johnson Services Inc.

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