Daiichi Sankyo and AstraZeneca could find out this week whether the European Medicines Agency will recommend that their drug, trastuzumab deruxtecan, should be granted pan-EU marketing approval for treating unresectable or metastatic HER2-positive breast cancer.
Moment Of Truth For Daiichi/AstraZeneca’s Enhertu In EU
The EU marketing application for the HER2-targeted antibody drug conjugate has been fast-tracked and is now up for an opinion from the European Medicines Agency.

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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.