FDA Approves J&J’s Darzalex Faspro for Sixth Multiple Myeloma Indication

FDA

The U.S. Food and Drug Administration (FDA) approved The Janssen Pharmaceutical Companies of Johnson & Johnson's Darzalex Faspro (daratumumab and hyaluronidase-fihj) with pomalidomide and dexamethasone for adults with multiple myeloma who have had a least one previous line of therapy, including lenalidomide and a proteasome inhibitor.

This is the sixth indication for Darzalex Faspro for multiple myeloma. It was based on data from the APOLLO trial, which hit the primary endpoint of improved progression-free survival (PFS), showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone. 

“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, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. 

“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.”

In August 2012, Janssen Biotech and Genmab inked a licensing deal giving Janssen an exclusive right to develop, manufacture, and commercialize daratumumab. The drug is the only CD38-directed antibody approved for subcutaneous treatment for multiple myeloma and AL amyloidosis. The drug is co-formulated with recombinant human hyaluronidase PHS20 (rHuPH20), Halozyme’s Enhanze drug delivery technology.

To date, Darzalex Faspro has been approved for adults 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 with ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma with one previous 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 with at least one previous therapy; with pomalidomide and dexamethasone in patients with at least one prior line of treatment including lenalidomide and a proteasome inhibitor; and by itself in patients who have received at least three previous lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

It is also approved in combination with bortezomib, cyclophosphamide, and dexamethasone for adults with newly diagnosed light chain amyloidosis, granted under an accelerated approval pathway based on response rate. Confirmatory trials will be conducted to verify the efficacy.

Multiple myeloma is an incurable blood cancer. It affects plasma cells found in the bone marrow. When damaged, plasma cells spread quickly and replace normal cells with bone marrow tumors. 

About 34,000 people are expected to be diagnosed with multiple myeloma in the U.S. this year, with approximately 12,500 deaths. It is possible to have no symptoms, but symptoms can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney issues, or infections.

“We are focused on the continued development of Darzalex Faspro and advancing this innovative therapy for patients who are in need of additional treatment options,” said Craig Tendler, vice president, Late Development and Global Medical Affairs, Janssen Research & Development

“Today’s approval further distinguishes Darzalex Faspro in the treatment of multiple myelomas as the first and only subcutaneously administered anti-CD38 monoclonal antibody approved in combination with the widely used pomalidomide and dexamethasone regimen.”

 

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