FDA Approves Janssen’s DARZALEX FASPRO® in Combination with Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma with Subcutaneous Administration in Just 3–5 Minutes

July 12, 2021 /BioonBIOON/ -- Janssen Pharmaceuticals, a Johnson & Johnson (JNJ) company, recently announced that the U.S. Food and Drug Administration (FDA）has approved the daratumumab subcutaneous (SC) formulation——Darzalex Faspro (daratumumab and hyaluronidase-fihj, daratumumab-hyaluronidase),In combination with pomalidomide and dexamethasone (D-Pd regimen) for the treatment of adult patients with multiple myeloma (MM), specifically: patients with MM who have received at least one prior therapy (including regimens containing lenalidomide and a proteasome inhibitor).

It is worth mentioning that,Darzalex Faspro is currently the first and only approved subcutaneous anti-CD38 monoclonal antibody for use in combination with the widely used pomalidomide plus dexamethasone regimen (Pd regimen) in the treatment of multiple myeloma.. This approval also marks the sixth indication for Darzalex Faspro in the treatment of multiple myeloma (MM). The approval is based on the results of the Phase 3 APOLLO study, the relevant data of which were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and recently published in *The Lancet*.TumorOncology》 (The Lancet Oncology).

Professor Meletios A. Dimopoulos, Principal Investigator of the APOLLO study and Head of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens, stated: "Clinical studies, including APOLLO, continue to demonstrate that daratumumab-based combination regimens significantly reduce the risk of disease progression in patients with multiple myeloma. With this latest approval, we can now combine pomalidomide and dexamethasone with subcutaneous daratumumab for patient treatment."This subcutaneous formulation can be administered within minutes, whereas intravenous formulations typically require several hours.”

In the treatment of multiple myeloma (MM), despite significant advances over the past decade, the disease remains a complex hematologic malignancy, and the management of relapsed or refractory disease is a particularly challenging area.

United StatesFDAThe approval of the D-Pd regimen for the treatment of MM is based on data from the Phase 3 APOLLO study (MMY3013). The study enrolled 304 patients with relapsed or refractory MM who had previously received at least one line of therapy, had been treated with lenalidomide and a proteasome inhibitor, and had documented disease progression.The results show,Compared with the pomalidomide plus dexamethasone (Pd) regimen, the D-Pd regimen significantly reduced the risk of disease progression or death by 37%.（HR=0.63，p=0.0018）。The median progression-free survival (PFS) for the D-Pd and Pd groups was 12.4 and 6.9 months, respectively.. In addition,Compared with the Pd group, the D-Pd group had a higher response rate., including: overall response rate (ORR: 69% vs 46%), complete response rate (CR: 25% vs 4%), very good partial response (VGPR) or better (51% vs 20%), minimal residual disease negativity rate (9% vs 2%). The safety profile of the D-Pd regimen was consistent with the known safety of Darzalex Faspro and the Pd regimen.

Multiple Myeloma (Image source: cancer.gov)

In Europe, this June, the subcutaneous (SC) formulation of daratumumab—Darzalex SC (European trade name: daratumumab and hyaluronidase)—was granted two marketing authorisations: (1) a combination regimen of Darzalex SC with bortezomib, cyclophosphamide, and dexamethasone (D-VCd regimen), for the treatment of newlyDiagnosisadult patients with systemic light chain (AL) amyloidosis; (2) Darzalex SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma (MM), specifically: patients who have received one prior therapy containing a proteasome inhibitor and lenalidomide and are lenalidomide-refractory, or patients who have received at least two prior therapies containing lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or following the last therapy.

It is worth noting that, in the United States and the European Union,Darzalex Faspro/Darzalex SC is the first and only approved drug for the treatment of AL amyloidosis, indicated for first-line treatment of newly diagnosed patients.Diagnosisadult patients with AL amyloidosis.

In August 2012, Genmab granted Janssen Biotech, Inc., a Johnson & Johnson company, an exclusive global license to develop, manufacture, and commercialize daratumumab. The development of the Darzalex Faspro/Darzalex SC formulations utilized Halozyme’s ENHANZE® drug delivery technology, with the formulation containing recombinant human hyaluronidase PH20 (rHuPH20).

Darzalex is the first approved fully human monoclonal antibody targeting CD38, featuring a unique and innovative mechanism of action that specifically binds directly to CD38, a key immunotherapeutic target on the surface of myeloma cells, to induce myeloma cell death through multiple mechanisms and achieve rapid response.

Darzalex was launched in 2015 and has since become a cornerstone therapy for the clinical treatment of multiple myeloma (MM), widely used in first-line, second-line, and multi-line treatment settings.

In China, Darzalex (Zhaoken®, daratumumab injection) was approved in July 2019, becoming the first approved CD38-directed fully human monoclonal antibody in China., the drug is approved as monotherapy for adult patients with relapsed and refractory multiple myeloma, specifically: patients who have previously received treatment including proteasome inhibitors and immunomodulatory agents, and whose disease progressed during or after their last treatment.

In April 2021, Darzalex received further approval in China for use in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy. The approval of this indication will further fill the treatment gap in China for relapsed or refractory multiple myeloma, bringing more innovative options to patients at earlier stages of treatment. (Bioon.com)

Original Source:Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse