Janssen Snags New Multiple Myeloma Indication for Darzalex Faspro

The FDA okayed the sixth indication for Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

FDA cleared Darzalex Faspro in combination with pomalidomide and dexamethasone (Pd) for the treatment, based on findings from the phase 3 APOLLO study, which were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and were recently published in The Lancet Oncology.

“Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma,” said Meletios A. Dimopoulos, M.D., principal study investigator and professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, in a Janssen statement.

“With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration,” Dimopoulos added.

Darzalex Faspro is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis, Janssen said. Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze drug delivery technology.

The APOLLO study found that Darzalex Faspro-Pd significantly reduced the risk of progression or death by 37%, compared to Pd alone. The median progression-free survival (PFS) for the Darzalex-Pd arm versus the Pd arm was 12.4 versus 6.9 months, respectively.

In addition, the overall response rate was significantly higher in Darzalex Faspro-Pd compared to Pd alone (69% versus 46%), as were the rates of complete response or better (25% versus 4%).

In addition to the new indication, Darzalex Faspro is indication to treat adult patients with multiple myeloma:

• in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
• in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
• in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteosome inhibitor
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent