Janssen Submits FDA Application for Subcutaneous Daratumumab for Relapsed, Refractory Multiple Myeloma


It can be administered as a fixed-dose formulation over approximately 3 to 5 minutes, which is significantly less time than the intravenous (IV) formulation.

Janssen Pharmaceuticals has announced the submission of FDA regulatory applications for the daratumumab subcutaneous formulation in combination with pomalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy.

According to a press release, it can be administered as a fixed-dose formulation over approximately 3 to 5 minutes, which is significantly less time than the intravenous (IV) formulation. The application is supported by positive findings from the phase 3 APOLLO study, which met its primary endpoint of significantly longer progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma who received pomalidomide and dexamethasone compared to pomalidomide alone.

The APOLLO study is an ongoing multicenter, phase 3, randomized, open-label study with 304 participants. The primary endpoint is PFS between treatment arms, and secondary endpoints include rates of overall response, very good partial response or better, complete response or better, and duration of response.

The pomalidomide and dexamethasone regimen received FDA approval for the IV formulation in 2017 for patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.

“The IV formulation of Darzalex, which is approved in combination with pomalidomide and dexamethasone, is an important option for patients with multiple myeloma,” said Craig Tendler, MD, vice president of late development and global medical affairs in oncology for Janssen Research and Development. “We are excited to pursue the subcutaneous formulation of Darzalex for this indication as we look to reduce administration time from hours to minutes compared with the IV formulation.”

Daratumumab was first approved as a monotherapy for the treatment of multiple myeloma in 2015, making it the first anti-CD38 monoclonal antibody approved anywhere in the world for multiple myeloma. CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the disease stage. Daratumumab binds to CD38 and inhibits tumor cell growth, causing myeloma cell death.

According to a press release, additional studies are investigating the use of subcutaneous daratumumab and Darzalex Faspro in the treatment of other malignant and pre-malignant hematologic diseases expressing CD38, including smoldering myeloma and light chain amyloidosis.


Janssen Submits Applications in US and EU Seeking Approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) Subcutaneous (SC) Formulation in Combination With Pomalidomide and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma [news release]. PR Newswire; November 12, 2020. https://www.prnewswire.com/news-releases/janssen-submits-applications-in-us-and-eu-seeking-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihjdarzalex-daratumumab-subcutaneous-sc-formulation-in-combination-with-pomalidomide-and-dexamethasone-for-pat-301171825.html/ Accessed November 20, 2020.

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