The poten­tial new myeloma ther­apy daratumumab ^[1] just got a little closer to being avail­able to U.S. multiple myeloma patients outside of clin­i­cal trials.

Johnson and Johnson (NYSE:JNJ) announced today that its Janssen sub­sid­i­ary has started the process of applying to the U.S. Food and Drug Admin­istra­tion (FDA) to have dara­tu­mu­mab approved as a new treat­ment for re­lapsed multiple myeloma.

In particular, Johnson and Johnson has started a rolling sub­mission of a biologics license appli­ca­tion to the FDA for dara­tu­mu­mab.

A rolling sub­mission allows Johnson and Jonson to submit com­pleted portions of its appli­ca­tion to the FDA on an ongoing basis. The FDA allows this appli­ca­tion sub­mission process in special situations where it believes a drug can be of sig­nif­i­cant benefit to patients who would be treated with it. Normally, the FDA requires com­pa­nies to submit approval appli­ca­tions that are com­plete in their entirety at the time of sub­mission.

Daratumumab was granted breakthrough ther­apy desig­na­tion by the FDA in 2013 (see related Beacon ^[2] news). Break­through ther­apy desig­na­tion is designed to acceler­ate the devel­op­ment and review process for drugs in­tended to treat serious or life-threatening illnesses.

Johnson and Johnson has not provided any guidance thus far on how long it ex­pec­ts it will take for the com­pany to com­plete the sub­mission of dara­tu­mu­mab’s approval appli­ca­tion. In addi­tion, because dara­tu­mu­mab has been designated as a breakthrough ther­apy, it is dif­fi­cult to predict how long the FDA will take to com­plete its review of dara­tu­mu­mab’s appli­ca­tion, once all of it has been submitted.

That said, The Beacon cur­rently esti­mates that the entire process will take until sometime during the first quarter of next year – that is, an FDA de­ci­sion on dara­tu­mu­mab’s appli­ca­tion for approval can be ex­pec­ted by March 31, 2016. (This esti­mated timeline was devel­oped with input from research analyst Mark Schoenebaum and his colleagues at the investment banking advisory firm Evercore ISI.)

Johnson and Johnson is applying to have dara­tu­mu­mab approved as a treat­ment for patients with multiple myeloma who have received at least three prior lines of ther­apy, in­clud­ing both a pro­te­a­some inhibitor and an immuno­modu­la­tory agent, or who are double resistant (refractory) to a pro­te­a­some inhibitor and an immuno­modu­la­tory agent.

The sub­mission in­cludes data from the so-called Sirius MMY2002 trial, a Phase 2 study of dara­tu­mu­mab that in­cludes multiple myeloma patients who received at least three prior lines of ther­apy, in­clud­ing both a pro­te­a­some inhibitor and an immuno­modu­la­tory agent, or who are double refractory to a pro­te­a­some inhibitor and an immuno­modu­la­tory agent.

The results of that study were presented earlier this week at the annual meeting of the American Society of Clinical Oncology (ASCO). The results show that nearly one third of the trial par­tic­i­pants – who had received a median of five prior ther­a­pies – responded to single-agent dara­tu­mu­mab. The median time to disease pro­gres­sion was 3.7 months, and the esti­mated one-year over­all survival rate was 65 per­cent (see related Beacon ^[3] news).

Because patients in the trial were heavily pre­treated, and because they received only single-agent dara­tu­mu­mab, myeloma specialists have been impressed by the efficacy (and safety) that dara­tu­mu­mab dem­onstrated during the trial.

Safety and efficacy data from another Phase 1/2 study, and safety data from three other clin­i­cal trials, also will be in­cluded in the dara­tu­mu­mab FDA appli­ca­tion.

Daratumumab is a mono­clonal anti­body that binds to a protein known as CD38, which is commonly found on the surface of myeloma cells. Once bound to a myeloma cell, dara­tu­mu­mab then attacks the cell while also signaling the patient's immune sys­tem to act against the cells.

Two other CD38 mono­clonal anti­bodies are also under devel­op­ment as poten­tial myeloma ther­a­pies: SAR650984 ^[4] and MOR202 ^[5]. In addi­tion, elotuzumab ^[6], a mono­clonal anti­body that targets a dif­fer­en­t protein found on myeloma cells, is also being in­ves­ti­gated as a poten­tial myeloma ther­apy.

Johnson & Johnson is devel­op­ing dara­tu­mu­mab in col­lab­o­ration with the Danish bio­technology com­pany Genmab.  The drug is cur­rently being tested in a number of multiple myeloma clin­i­cal trials, involving both newly diag­nosed and re­lapsed patients.

For more in­for­ma­tion, please see the Johnson & Johnson ^[7] and Genmab ^[8] press releases.