Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Biotech, Inc. has recently submitted a supplemental Biologics License Application (sBLA) for DARZALEX (daratumumab) to the US Food and Drug Administration (FDA).

sBLA Application

Along with the sBLA, Janssen has also filed a Priority Review, which will be considered within 60 days following application. Should the FDA grant it, the sBLA will be reviewed and decided upon within six months of the application.

In November 2015, the FDA approved DARZALEX as a monotherapy for the treatment of multiple myeloma patients who have previously received at least three lines of therapy. The company is hoping to expand the indication of daratumumab, combining it with either lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of multiple myeloma among patients who had previously received at least one therapy. Last month, the FDA had granted daratumumab a Breakthrough Therapy Designation for the said indication.

Supporting Data

Peter Lebowitz, M.D., Ph.D., Janssen Research and Development, LLC Head of Global Oncology, reiterated that the drug has demonstrated potential as a treatment for multiple myeloma.

Janssen has also submitted to supporting data from two Phase 3 clinical trials, CASTOR (MMY 3004) and POLLUX (MMY 3003) following a mythological acronym theme; and a Phase 1 clinical trial.

Presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO), the CASTOR clinical trial had shown that the combination of daratumumab, bortezomib, and dexamethasone reduces the disease progression risk or fatality by 61%. Consequently, the safety of the said combination is established and consistent with those of daratumumab monotherapy, and bortezomib and dexamethasone, respectively.

Meanwhile, as presented at the 21st Annual Congress of the European Hematology Association (EHA), the POLLUX clinical trial had demonstrated that the combination of daratumumab, lenalidomide, and dexamethasone reduces the disease progression risk or mortality by 63%. Consequently, the safety of the said combination is established and consistent with those of daratumumab monotherapy, and lenalidomide and dexamethasone, respectively.

The Phase 1 clinical trial of daratumumab combined with pomalidomide and dexamethasone among multiple myeloma patients who have previously received at least two lines of therapy was also included in the sBLA filing.