FDA — authorised 19 September 2025
- Application: BLA761467
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: KEYTRUDA QLEX
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 KEYTRUDA QLEX in United States
FDA authorised KEYTRUDA QLEX on 19 September 2025
Marketing authorisations
FDA
- Status: approved
KEYTRUDA QLEX in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is KEYTRUDA QLEX approved in United States?
Yes. FDA authorised it on 19 September 2025; FDA has authorised it.
Who is the marketing authorisation holder for KEYTRUDA QLEX in United States?
MERCK SHARP DOHME holds the US marketing authorisation.