Legend Biotech’s BCMA CAR-T Therapy Carvykti (Ciltacabtagene Autoleucel) Package Insert

Legend Biotech’s BCMA CAR-T Therapy Carvykti (Ciltacabtagene Autoleucel) Package Insert

On February 28, 2022, the FDA officially approved Ciltacabtagene autoleucel, a BCMA CAR-T therapy developed by Legend Biotech/Janssen, for the treatment of relapsed or refractory multiple myeloma. The commercial name for this product is Carvykti.

Carvykti approved for launch in the United States

Legend Biotech/Janssen priced Carvykti at $465,000, higher than the $419,500 price tag for Abecma, the BCMA CAR-T therapy developed by Bristol Myers Squibb.


On March 3, the FDA officially released the prescribing information for Carvykti on its website.

Key points of Carvykti prescription

The dosage of Legend Biotech/Janssen’s Carvykti is 0.5-1.0×10^6/kg, with a maximum of 1×10^8 cells. In contrast, the dosage of Bristol Myers Squibb’s Abecma is 3.0-4.6×10^8 cells, which is more than three times higher than Carvykti.

Carvykti usage and dosage

Carvykti dosage form

Carvykti employs a bispecific nanobody design and demonstrated an overall response rate (ORR) of 97.9% and a stringent complete response (sCR) rate of 78.4%, with a median duration of response (mDoR) of 21.8 months.

Carvykti cartitude-1 treatment data

Summary of efficacy results of carvykti cartitude-1

In comparison, Abecma had an ORR of 72%, sCR of 28%, and mDoR of 11 months. When compared side by side, Carvykti demonstrated superior efficacy.

Carvykti summary of efficacy based on independent response committee review

Carvykti response time

Carvykti may contain a small amount of NK cells.

Introduction to carvykti

How to use carvykti

The incidence of anti-drug antibodies (ADA) was 19.6% for Carvykti and 47% for Abecma.

Immunogenicity of carvykti

Immunogenicity of abecma

In summary, Legend Biotech’s successful approval of Carvykti paved the way for innovative Chinese biopharmaceuticals to enter the European and American markets. It also highlighted the clinical value and market value of differentiated innovative products. In the coming years, more and more innovative drugs developed in China will compete in the global market.

Content Source:医药笔记

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