EMA OKs two new drugs — J&J's BCMA CAR-T for multiple myeloma, AstraZeneca's Evusheld — plus 5 label expansions
The European Medicines Agency’s CHMP on Friday recommended two new drugs for approval, AstraZeneca’s Evusheld to help prevent Covid-19, and Johnson & Johnson’s new BCMA CAR-T fourth-line treatment for multiple myeloma.
Approved in the US about four weeks ago, J&J and Legend’s new drug, sold as Carvykti, will rival BMS and bluebird bio’s BCMA CAR-T Abecma, although Legend and Janssen say some long-term data suggest they may have an advantage. While in the EU the Commission still needs to sign off on Carvykti for full approval, the CAR-T is launching in the US at $465,000, according to Scott White, J&J’s company group chairman of North America pharmaceuticals — which is higher than Abecma’s $419,500 price tag.
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