Darzalex is first biologic drug and first monoclonal antibody approved for multiple myeloma
On Monday, a Johnson & Johnson drug has won Food and Drug Administration (FDA) approval for the treatment of the incurable blood cancer multiple myeloma in patients who were not able to succeed in past therapies and are left with a few options only.
Darzalex is the first ever biologic drug and monoclonal antibody that has got approval for multiple myeloma. The National Cancer Institute has estimated that in 2015, the cancer, occurring in infection-fighting white blood cells in the bone marrow will be striking 26,850 Americans and take lives of nearly 11,240 people.
The drug Darzalex is chemically called daratumumab. It aids immune system cells in attacking malignant multiple myeloma cells by fixing to a protein on their surface. According to Johnson & Johnson's Janssen biologic drug unit, then the infused drug is believed to trigger death of tumor cells via a number of mechanisms.
According to the head of FDA's Office of Hematology and Oncology Products, Dr. Richard Pazdur, such targeting of proteins cancer cells' surface has given way to significant new cancer treatments.
The drug has been granted accelerated approval by FDA on the basis of 2 studies that showed Darzalex cut the size of or eliminated tumors in nearly one-third of patients.
In one study, 106 patients took part and 29% of them responded to the drug Darzalex for 7.4 months, on average, prior to tumor growth resumed. In the second study that included 42 patients, 36% got their tumors reduced or eliminated. Further testing is in process by Janssen.