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.
You may also be interested in...
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.
The selective PI3K inhibitor, alpelisib, met its primary PFS endpoint in top-line data from the SOLAR-1 study, but further details are needed from the trial in order to judge the drug's likely penetration of the HR-positive, HER2-negative breast cancer population.