Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has approved Janssen Biotech's Darzalex (daratumumab) to treat multiple myeloma (MM) patients who have received at least three prior lines of therapy.
Subscribe to our email newsletter
Darzalex is a monoclonal antibody that is designed to help the body’s immune system fight cancer cells.
In clinical studies involving over 140 people, Darzalex reduced the cancer’s spread by 29% to 36%.
The drug’s most common side effects included infusion-related reactions, fatigue, nausea, back pain, fever and cough. It could also reduce white blood cells, red blood cells and blood platelets.
Janssen said Darzalex is believed to induce tumor cell death through apoptosis, in which a series of molecular steps in a cell lead to its death and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
The recommended dose of Darzalex is 16 mg/kg body weight 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 9 to 24. It should be administered for every four weeks from week 25 onwards until disease progression.
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 tumor types."
Janssen licensed Darzalex from Genmab in August 2012. Janssen is presently the worldwide sponsor of all but one clinical study.
Image: Darzalex is a monoclonal antibody that is designed to help the body’s immune system fight cancer cells. Photo: courtesy of Johnson & Johnson Services, Inc.