Novartis's Piqray Gets Europe Green Light At Last
First-In-Class PI3K inhibitor Approved For Breast Cancer
It has taken a while but European regulators have finally followed their US counterparts and approved Piqray, making it the first targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
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Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.
In an interview at Novartis' research campus in Cambridge, Mass., Schaffert spoke about the upcoming launch of Piqray for breast cancer, building in radiopharmaceuticals, Kymriah's ongoing manufacturing challenges and more.