🇺🇸 Kadcyla in United States

FDA authorised Kadcyla on 22 February 2013

Marketing authorisation

FDA — authorised 22 February 2013

  • Application: BLA125427
  • Marketing authorisation holder: GENENTECH
  • Local brand name: KADCYLA
  • Indication: VIAL — SINGLE-USE
  • Status: approved

The FDA approved Kadcyla, manufactured by Genentech, for its approved indication on 26 March 2026. This approval was granted through a standard expedited pathway. The application number for this approval is BLA125427.

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Pricing & reimbursement

Kadcyla in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Kadcyla approved in United States?

Yes. FDA authorised it on 22 February 2013.

Who is the marketing authorisation holder for Kadcyla in United States?

GENENTECH holds the US marketing authorisation.

What does Kadcyla cost in United States?

annual_list: USD 59000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.