Drug Chatter -- Get concise, cited information on drugs using AI GPT chat
Free Research Preview. DrugChatter may produce inaccurate information.

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

When was keytruda's initial fda approval?

See the DrugPatentWatch profile for keytruda

When did FDA first approve Keytruda (pembrolizumab)?

Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014. [1]

What was Keytruda’s first FDA approval for?

FDA first approved Keytruda for the treatment of unresectable or metastatic melanoma in patients with progression on or after other therapies, or for whom no satisfactory alternative treatment options existed. [1]

Does the approval date differ by cancer type or label expansion?

The FDA’s initial approval date stays the same, but Keytruda’s label has expanded over time to include additional cancers and treatment settings after 2014. [1]

Sources

  1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514


Other Questions About Keytruda :

How often should keytruda be administered? Extended patent keytruda? Keytruda patent expiry and generic filing or anda and biosimilar and 2024 or 2025 or 2026? Can keytruda cause weight gain? When did keytruda receive fda approval for general cancer use? Which cancer type did keytruda first gain fda approval in? Are there cost effective keytruda alternatives with similar efficacy?

AI-Drug Label Prescribing Information Alignment Report

No report available.

Drug Brand Mention Assessment

Branding Score
67
Visibility
79
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

initial FDA approval on September 4, 2014


Core Claims
  • Keytruda received its initial FDA approval on September 4, 2014
  • FDA first approved Keytruda for unresectable or metastatic melanoma
  • Label expanded over time after 2014
Differentiators

Pricing Perception: Not Mentioned