Carvykti Price and Brief Introduction

Carvykti Price and Brief Introduction

Ciltacabtagene Autoleucel, a CAR-T product from China, received FDA approval in March 2022 and EU approval on May 26th of the same year, marking an unprecedented achievement.

Legend Biotech

Legend Biotech

Ciltacabtagene Autoleucel Introduction

Drug Name: Ciltacabtagene Autoleucel, Cilta-Cel

Brand Name: Carvykti

Target: BCMA

Indication: Relapsed or Refractory Multiple Myeloma (R/R MM) patients

Price: $465,000

Carvykti (Ciltacabtagene Autoleucel) is a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It utilizes the patient’s own T cells, which are genetically engineered to express a chimeric antigen receptor (CAR) that recognizes and eliminates BCMA-expressing cancer cells.

BCMA is primarily expressed on the surface of malignant multiple myeloma B cells, late-stage B cells, and plasma cells. CARVYKTI®’s CAR protein contains two BCMA-targeting single-domain antibodies, conferring high affinity for BCMA-expressing cancer cells. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, proliferation, and subsequent elimination of cancer cells.

In December 2017, Janssen entered into an exclusive global licensing and collaboration agreement with Legend Biotech to develop and commercialize CARVYKTI®. In April 2021, Legend Biotech announced the submission of a marketing authorization application to the European Medicines Agency, seeking approval for Cilta-cel in the treatment of relapsed or refractory multiple myeloma patients. In addition to receiving Breakthrough Therapy Designation (BTD) in the U.S. in December 2019, Cilta-cel was included in the “Breakthrough Therapy Drugs” program in China in August 2020. The FDA and EMA granted Cilta-cel Orphan Drug Designation in February 2019 and February 2020, respectively.

Legend Biotech Introduction

Founded in 2014, Legend Biotech (NASDAQ: LEGN) is a global, cross-national biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of cell-based immunotherapies for cancer. It is a leader in the field of immune cell therapy, with a global workforce exceeding 1,000 employees. Currently, in collaboration with Janssen Biotech, Inc. (“Janssen”), the company has brought its core product to the marketing authorization review stage in the U.S. and Europe, poised to address a significant unmet need in the treatment of multiple myeloma. Additionally, the company has multiple CAR-T therapies in development for the treatment of hematological malignancies, solid tumors, and other complex diseases.

Overall Response Rate of 98%! Chinese CAR-T Therapy Rewrites History!

This approval was primarily based on the results of the CARTITUDE-1 Phase 1b/2 study, which yielded remarkably encouraging data.

Among the 97 late-stage multiple myeloma patients with no better treatment options enrolled in the clinical trial, the administration of Legend Biotech’s CAR-T therapy led to early, deep, and durable responses. The overall response rate (ORR) was an astonishing 98% (95% CI: 92.7-99.7), with 78% of patients achieving stringent complete response (sCR, 95% CI: 68.8-86.1), meaning that nearly 80% of late-stage patients experienced complete elimination of their disease after receiving CAR-T therapy! Furthermore, the 12-month progression-free survival (PFS) rate was 77% (95% CI, 66.0%-84.3%), and the overall survival (OS) rate was 89% (95% CI, 80.2%-93.5%).

Legend Biotech’s CEO and CFO, Dr. Ying Huang, stated: “Multiple myeloma remains an incurable disease, and patients who have received multiple prior lines of therapy face poor prognoses and limited treatment options. The approval of CARVYKTI® is a significant milestone for Legend Biotech, marking our first product approval since the company’s inception. More importantly, this therapy has the potential to become a new, effective treatment option for patients in need of prolonged treatment-free intervals.”

Multiple myeloma is a malignant tumor caused by the proliferation of plasma cells in the bone marrow. Most patients relapse after initial treatment and have poor prognoses after receiving major drugs such as immunomodulators, proteasome inhibitors, and anti-CD38 antibodies.

Dr. Sundar Jagannath, Professor of Hematology/Oncology at the Mount Sinai School of Medicine and a principal investigator in the study, exclaimed: “The study demonstrated that CARVYKTI® can provide deep and durable responses in multiple myeloma patients, even after multiple lines of therapy. The approval of CARVYKTI® holds the promise of addressing this significant unmet need.”

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