CARVYKTI (cilta-cel) by Legend Biotech / Johnson & Johnson: status and timeline

CARVYKTI (cilta-cel)

Deliver a best-in-class CAR-T therapy for multiple myeloma and other blood cancers, with global manufacturing and distribution to expand patient access.

ScalingStage 5 of 5

Best-selling CAR-T globally with $657M Q2 2026 sales; available at 348 sites in 19 markets.

Updated Q2 2026Checked 11 Oct0 updates this week

Milestones

Next · Global expansion to 348 treatment sites

CARVYKTI clinical data presented at ASCO2017Complete.
Janssen Biotech partnership signed2017Complete.
FDA approval for multiple myelomaFeb 2022Complete.
Global expansion to 348 treatment sitesTarget Jun 2026Current milestone.

Most important updates

Upcoming

Jun 2026Global expansion to 348 treatment sites (next)
Dec 2026LB2501 IND filing (next-generation in vivo CAR-T)

Current obstacles

Manufacturing complexity and costEach CARVYKTI dose requires individual patient cell collection and manufacturing, making the therapy expensive and limiting capacity.
Treatment-related toxicitiesCAR-T therapy can cause cytokine release syndrome and other immune-related adverse events requiring careful patient selection and monitoring.

Physics limits

Patient-specific manufacturingEach treatment requires custom manufacturing from the patient's own cells, limiting scalability and increasing complexity versus off-the-shelf medicines.
Manufacturing site requirementsThe need for GMP-certified manufacturing facilities and treatment centers with specialized expertise limits treatment availability.
Cell therapy shelf lifeFrozen cell therapies have limited shelf stability, requiring careful logistics and reducing flexibility in treatment scheduling.

How it works

4 parts

Cell Collection

Patient T-cell apheresis

T cells are collected from the patient's blood through apheresis, a process that separates specific cell types.

Engineering

CAR gene insertion

The collected T cells are genetically modified in the laboratory to express a CAR targeting BCMA, the antigen found on multiple myeloma cells.

Expansion

In vitro cell expansion

The CAR-T cells are expanded in culture to generate sufficient numbers for therapy, then frozen for shipment to the treatment center.

Infusion

Patient infusion

The CAR-T cells are thawed and infused back into the patient where they recognize and kill BCMA-expressing cancer cells.

Spec sheet

Spec	CARVYKTI (cilta-cel)
Q2 2026 net trade sales	$657 million^R (reported)
Year-over-year sales growth	+50%^R (reported)
Global treatment sites	348^R (reported)
Market presence	19 global markets^R (reported)

^R reported by the company

Papers & demos

1 item

2017demo
Anti-BCMA CAR-T clinical data presented at ASCO (opens asco.org)Presentation of cilta-cel (CARVYKTI) clinical data led to partnership agreement with Janssen Biotech for co-development.

Update log

2 updates

Q2 2026

Major: CARVYKTI achieves $657M in Q2 2026 sales, up 50% year-over-yearFilingCommercial

Feb 2022

Major: CARVYKTI (cilta-cel) receives FDA approval for multiple myelomaPressRegulatory

About Legend Biotech / Johnson & Johnson

The team behind CARVYKTI (cilta-cel)

Legend Biotech / Johnson & Johnson

CARVYKTI CAR-T cell therapy

Legend Biotech develops CARVYKTI (ciltacabtagene autoleucel), a CAR-T cell therapy for treating multiple myeloma and other blood cancers. The company partners with Johnson & Johnson's Janssen Biotech for development and global commercialization.

CARVYKTI: $657M Q2 2026 sales (+50% YoY) at 348 sites in 19 markets; best-selling CAR-T.
First company-wide profitability in Q2 2026; $63M adjusted net income, expected through H2.
LB2501 in vivo CAR-T: 83.3% complete-response rate; IND filing planned by end of 2026.

legendbiotech.com (opens legendbiotech.com)Company profile →

Founded: 201412 yrs
Headquarters: United States
Status: Public
Valuation: public
Works in: BiotechCell & organ therapies
Coverage: 1 program · 4 updateslatest 1 Aug 2026checked 11 Oct
Partners: Janssen Biotech (Johnson & Johnson) (opens jnj.com)
People: Alan Bash (opens legendbiotech.com)Interim CEO

Spec

CARVYKTI (cilta-cel)

Q2 2026 net trade sales

$657 million^R (reported)

Year-over-year sales growth

+50%^R (reported)

Global treatment sites

348^R (reported)

Market presence

19 global markets^R (reported)