Janssen Seeks US Approval of Darzalex Combo for Newly Diagnosed Multiple Myeloma

Janssen Pharmaceuticals has requested the U.S. Food and Drug Administration (FDA) add a new indication for Darzalex (daratumumab) in combination with other therapies to treat patients with multiple myeloma who are not eligible for stem cell transplants.

This follows a similar application to the European Medicines Agency (EMA) to broaden the existing marketing authorization for Darzalex in the European Union.

“The addition of Darzalex to this treatment regimen provides a substantial, clinically meaningful impact on prolonging remission for newly diagnosed patients with multiple myeloma,” Mark Wildgust, vice president of Global Medical Affairs at Janssen Oncology, said in a press release. “Today’s submission builds upon the consistent clinical benefit of Darzalex in combination with standard of care regimens and is an exciting step forward for patients and physicians.”

Janssen submitted a supplemental biologics license application to the FDA to obtain a license to market the product for a new indication. The application is based on data from the Phase 3 ALCYONE study (NCT02195479) that tested Darzalex in combination with Velcade (bortezomib), Alkeran (melphalan), and prednisone as first treatment in cases of multiple myeloma.

Data from the ALCYONE study were accepted as a late-breaking abstract, titled “Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE),” at the 59th Annual Meeting of the American Society of Hematology, scheduled for early December 2017.

The trial results showed that adding Darzalex to the Velcade, Alkeran, and prednisone (VMP) combo reduced the risk of disease progression by half in myeloma patients who could not tolerate a stem cell transplant.

Response rates were also better in the Darzalex group compared to patients receiving Velcade, Alkeran, and prednisone alone. Also, more patients in the Darzalex group had good partial and complete responses and were negative for minimal residual disease.

The FDA first approved Darzalex in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who do not respond to both.

In November 2016, the FDA granted additional approvals for the use of Darzlex in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade and dexamethasone, for the treatment of patients with multiple myeloma who have already received at least one therapy.

In June 2017, the FDA approved Darzalex in combination with Pomalyst (pomalidomide) and dexamethasone for the treatment of patients with multiple myeloma who have already received at least two therapies, including Revlimid and a proteasome inhibitor.

Darzalex works by attaching itself to multiple myeloma cells in the body and directly killing them or allowing the immune system to destroy them.