FDA Grants Expanded Access to Multiple Myeloma Drug


Access is open to US adult patients who are refractory to the most common anti-myeloma drug classes.

Access is open to US adult patients who are refractory to the most common anti-myeloma drug classes.

Multiple myeloma patients in immediate need of new treatment options can receive Janssen’s investigational daratumumab through an expanded access program (EAP).

The EAP is open to US adult patients who are refractory to 2 of the most commonly used anti-myeloma drug classes—proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs)—or have received 3 or more prior therapies that include a PI and an IMiD.

Up to 40 health care centers will enroll patients for the daratumumab EAP, which is supported by the Multiple Myeloma Research Foundation and will be conducted as a clinical trial program to provide access to the drug prior to its potential FDA approval.

“We understand that heavily pre-treated or double refractory patients are in immediate need of new treatment options," said Craig Tendler, MD, vice president of late development and global medical affairs in oncology at Janssen. "…Our goal is to provide timely access to daratumumab for multiple myeloma patients who may benefit while its application is under review with the FDA.”

Janssen initiated a rolling Biologics License Application for daratumumab last month to speed the approval process for the drug, which was granted Breakthrough Therapy Designation in May 2013.

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