🇺🇸 Cilta-cel in United States

Cilta-cel (Cilta-cel) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Cilta-cel in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Cilta-cel approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Cilta-cel in United States?

Janssen Research & Development, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.