Carvykti FDA Approval for the Treatment of Relapsed or Refractory Multiple Myeloma

Carvykti FDA Approval for the Treatment of Relapsed or Refractory Multiple Myeloma

FDA Approves The Listing Of Carvykti

On February 28, 2022, Legend Biotech Corporation (LEGN) announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In December 2017, Legend Biotech entered into a worldwide exclusive license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

CARVYKTI™ is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy, which is administered as a one-time infusion at a recommended dose range of 0.5 to 1.0 x 106 CAR-positive viable T cells per kg of body weight. In the pivotal CARTITUDE-1 study, RRMM patients (n=97) experienced deep and durable responses, with an overall response rate (ORR) of 98% (95% confidence interval [CI]: 92.7-99.7), and 78% of patients achieved stringent complete response (sCR; 95% CI: 68.8-86.1). At the median follow-up of 18 months, the median duration of response (DOR) was 21.8 months (95% CI: 21.8-not estimable).



The safety information for CARVYKTI™ includes cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), and prolonged and/or recurrent cytopenias. Warnings and precautions include prolonged and recurrent cytopenias, infections, hypogammaglobulinemia, allergic reactions, secondary malignancies, and effects on ability to drive and use machines.1 The most common adverse reactions (≥20%) were fever, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infection with unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

An Overview of CARVYKTI

CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate cells expressing BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, mature B-cell lymphocytes, and plasma cells. The CARVYKTI™ CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity binding to human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, proliferation, and target cell elimination.

In April 2021, it was announced that a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency, seeking approval of CILTE-CEL for the treatment of relapsed and/or refractory multiple myeloma. In addition to the U.S. Breakthrough Therapy Designation received in December 2019, cilta-cel received Breakthrough Therapy Designation in China in August 2020. It also received Orphan Drug Designation from the U.S. FDA and the European Commission in February 2019.


CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, single-arm, multi-center study evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. In 2022, it is estimated that over 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the United States. While some patients with multiple myeloma have no symptoms, most patients at diagnosis present with symptoms that can include bone problems, low blood counts, calcium elevation, kidney issues, or infections.8 Although treatment may result in remission, unfortunately, patients will most likely relapse. Patients who relapse after treatment with standard therapies (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies) have poor prognoses and limited treatment options available.

Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating and one day defeating life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D locations around the world, we apply these innovative technologies to pursue the discovery of safe, effective and cutting-edge therapeutics for patients worldwide.

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