Photo by Linda Bartlett
A new expanded access program (EAP) will make daratumumab, an investigational anti-CD38 monoclonal antibody, available to patients with double-refractory multiple myeloma (MM).
The multicenter EAP is open to MM patients in the US who are 18 years of age or older.
Patients must be refractory to both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or have received 3 or more prior lines of therapy, including a PI and an IMiD.
In the US, EAPs are designed to make investigational medicines available for patients with serious or life-threatening illnesses who are ineligible for ongoing interventional trials and have exhausted currently available treatment options.
This EAP will make daratumumab available at up to 40 medical centers in the US while the drug’s Biologics License Application is under review by the US Food and Drug Administration (FDA).
Additional information about the EAP can be found on clinicaltrials.gov (NCT02477891). Janssen Research & Development, LLC, the company developing daratumumab, is collaborating with the Multiple Myeloma Research Foundation on this EAP.
About daratumumab
Daratumumab is a human IgG1k monoclonal antibody that binds with high affinity to the transmembrane ectoenzyme CD38 on the surface of MM cells.
Five phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess the drug’s potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma.
On May 1, 2013, daratumumab received breakthrough designation from the FDA for the treatment of patients with MM who have received at least 3 prior lines of therapy, including a PI and an IMiD, or who are double refractory to a PI and an IMiD.
On June 5, 2015, Janssen announced it had initiated the rolling submission of its Biologics License Application for daratumumab to the FDA for the treatment of this set of MM patients. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.
The regulatory submission for daratumumab will be primarily supported by data from the phase 2 MMY2002 (SIRIUS) study, the results of which were presented at the 2015 ASCO Annual Meeting.
The application will also be supported by data from 4 other studies, including the phase 1/2 GEN501 monotherapy study.
