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Biomarker Is King In Latest US FDA Cancer Drug Approval

 
• By Mary Jo Laffler

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US regulatory agency has granted an indication that does not specify the location of the tumor – a change that precision-medicine researchers have been eager to make.

FDA's approval of Merck's Keytruda (pembrolizumab) for use in any patient with a solid tumor with a particular genetic mutation is the first of its kind and could be the herald of a new approach to treating cancer.

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More from Policy & Regulation

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.