Keytruda's Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope

01 Sep 2021

US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.

Narrow opening — FDA has narrowed the first-line urothelial carcinoma population for Keytruda. • Source: Alamy

The US Food and Drug Administration opted to rely on longer-term follow-up from Merck & Co., Inc.’s original single-arm trial, rather than additional confirmatory studies, as the basis for converting Keytruda’s (pembrolizumab) accelerated approval in first-line urothelial carcinoma to regular approval.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

EU Biosimilar Filings, Opinions And Approvals

22 Apr 2025

• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

17 Apr 2025

• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

16 Apr 2025

• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

African Medicines Agency Set To Launch With New Leader In April

15 Apr 2025

• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

18 Apr 2025

• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.