1. Pink Sheet

Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls

 
• By Vibha Sharma

The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.

Multiple myeloma (cancer type) diagnosis medical concept on tablet screen with stethoscope.
Cilta-Cel is a one-time autologous treatment for multiple myeloma • Source: Alamy

Sponsors of six new drugs are set to learn this week whether their products are on track for possible EU-wide approval, including Janssen for its CAR-T therapy for multiple myeloma ciltacabtagene autoleucel (cilta-cel) and AstraZeneca for its COVID-19 preventive treatment Evusheld (tixagevimab/cilgavimab).

Cilta-cel was authorized as Carvykti in the US three weeks ago, while Evusheld was approved for emergency use in the US last year

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