Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review

Pneumococcal Vaccine & Four New Drugs Also Up For CHMP Opinion

 
• By Vibha Sharma
  
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Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.

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Yes Or No? It’s Decision Time For Some New Drugs At CHMP Meeting This Week • Source: Alamy

Gilead Sciences is set to learn this week whether its breast cancer treatment, sacituzumab govitecan, is on track to receive EU-wide marketing approval. The drug is authorized as Trodelvy in five other countries via Project Orbis, a US-led initiative that provides for the concurrent submission and review of high-impact oncology drugs among participating international health authorities.

In the EU, sacituzumab govitecan seems to have breezed through the regulatory evaluation process. It was accepted for fast-track evaluation...

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