FDA approves ‘first of its kind’ blood cancer drug
pharmafile | November 17, 2015 | News story | Manufacturing and Production, Research and Development |
The FDA has approved Genmab’s drug Darzalex for patients with multiple myeloma.
Darzalex (daratumumab) is the first human CD38 monoclonal antibody to have been approved anywhere in the world and it is the first therapeutic antibody ever approved to treat multiple myeloma.
The treatment will be given by intravenous infusion to those who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or people whose tumour has not responded after treatment with both types of drugs.
In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize Darzalex. As a result, Genmab will receive a milestone payment from Janssen of $45 million once the drug goes on sale in the US.
Jan van de Winkel, chief executive of Genmab says: “This is an important day for patients in the United States with double refractory multiple myeloma, who will now have Darzalex as a new treatment option for this incurable disease. The successful approval of Darzalex is the culmination of many years of hard work, perseverance and collaboration on the part of clinical study investigators, Genmab employees and our colleagues at Janssen.
“Our work at Genmab is aimed at improving the lives of patients and we are both proud and humbled to have created this first-in-class therapeutic antibody and to have played a key part in the rapid and expansive development of Darzalex.”
Speaking at the FT Global Pharmaceutical and Biotechnology conference in London, van de Winkel said the partnership with Janssen had been ‘crucial’ in getting Darzalex to market. “Our collaboration with Janssen has really helped us push forward with Darzalex, and I have to say the Janssen partnership brought a lot of good things to the table, and you’re seeing the fruits of that now with Darzalex.”
The approval follows a pivotal Phase II MMY2002 (SIRIUS) study which showed treatment with single-agent Darzalex resulted in an overall response rate of 29.2% in patients who received a median of five prior lines of therapy. The approval comes just two months after the Biologics License Application (BLA) was accepted for Priority Review by the FDA in September 2015.
Yasmita Kumar
