Carvykti FDA Approval Press Release,Legend Biotech’s Carvykti Approved in the U.S. for Second-Line Treatment of Relapsed or Refractory Multiple Myeloma

Carvykti FDA Approval Press Release,Legend Biotech’s Carvykti Approved in the U.S. for Second-Line Treatment of Relapsed or Refractory Multiple Myeloma

Carvykti is approved for second-line treatment

This one-time infusion therapy’s new indication will provide treatment-free remission for patients with first relapse.

On April 5, 2024, local time, Legend Biotech (NASDAQ: LEGN) announced in Somerset, New Jersey, USA, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide1. CARVYKTI® is the first and only approved B-cell maturation antigen (BCMA)-directed therapy for the second-line treatment of multiple myeloma, including CAR-T therapy, bispecific antibodies, and antibody-drug conjugates (ADCs).

Expert Comments

Dr. Ying Huang

Chief Executive Officer, Legend Biotech

“The expanded indication for CARVYKTI® is expected to change the treatment paradigm for multiple myeloma, providing physicians and patients with a personalized immunotherapy that can be used earlier in the treatment journey. Multiple myeloma is an incurable and relapsing blood cancer, leading patients to experience relapse and develop resistance, underscoring the critical need for innovative treatment options. We are committed to improving the lives of blood cancer patients and remain dedicated to developing cell therapies that can offer a potential cure.”

The FDA approval was based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® significantly improved progression-free survival (PFS) compared to two standard-of-care regimens, Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy, representing a statistically significant and clinically meaningful result. This approval came after a unanimous (11-0) vote by the Oncologic Drugs Advisory Committee (ODAC) in support of CARVYKTI® for earlier line use.

Dr. Surbhi Sidana

Assistant Professor of Medicine,

Hematology and Blood and Marrow Transplantation and Cellular Therapy,

Stanford University School of Medicine

“The results from CARTITUDE-4 demonstrate a significant clinical benefit of receiving Ciltacabtagene Autoleucel over continued standard-of-care therapy for patients who have relapsed after one to three prior lines of treatment. This FDA approval to expand the indication for Ciltacabtagene Autoleucel will allow more patients to access this innovative therapy earlier in their treatment journey.”

Birk Vanderweeën

Senior Vice President, Global Manufacturing and Supply, Legend Biotech

“This approval to expand the indication underscores the growing demand for CARVYKTI®, meaning more patients will gain access to this life-changing personalized therapy. Our global manufacturing team and partners have scaled up capacity to meet the increasing demand for this customized therapy, and we remain focused on further expanding operations to ensure patient access to CARVYKTI®.”

CARVYKTI® has a BOXED WARNING for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome and their associated complications, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and recurrent cytopenias, and secondary malignancies (including myelodysplastic syndrome, acute myeloid leukemia and T-cell malignancies).1 Precautions include increased early mortality, infections, hypogammaglobulinemia, allergic reactions, and effects on ability to drive and use machines.1

The most common non-laboratory adverse reactions (incidence greater than 20%) were fever, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infection of unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infection, coagulopathy, constipation, and vomiting.1 The most common Grade 3 or 4 laboratory abnormalities (greater than or equal to 50%) included lymphocyte count decreased, neutrophil count decreased, white blood cell count decreased, platelet count decreased, and hemoglobin decreased.1

About CARTITUDE-4

CARTITUDE-4 (NCT04181827) is an international, randomized, open-label Phase 3 study evaluating the efficacy and safety of Ciltacabtagene Autoleucel versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in adults with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy, with progression-free survival (PFS) as the primary endpoint2.

Reference Material

[1] CARVYKTI™ 处方信息。Horsham, PA: Janssen Biotech, Inc.

[2] ClinicalTrials.gov. 靶向BCMA的CAR-T疗法JNJ-68284528与泊马度胺、硼替佐米和地塞米松(PVd)或达雷妥尤单抗、泊马度胺和地塞米松(DPd)在复发和来那度胺耐药的多发性骨髓瘤患者中的比较研究(CARTITUDE-4)。https://clinicaltrials.gov/study/NCT04181827。2024年3月访问

[3]美国临床肿瘤学会，多发性骨髓瘤简介。https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html。2024 年 3 月访问

[4] 美国癌症协会，关于多发性骨髓瘤的关键统计数据。 https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. 2024年3访问

[5]美国癌症协会，多发性骨髓瘤：早期检测、诊断和分期。https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. 2023年3月访问

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