Biotech | July 24, 2023
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
Pfizer is likely to show GSK significant competition
European approval is based on robust Phase III data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1,3-5
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
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