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EU Indication Restricted For Novartis's Newly Approved Piqray

Patients Previously Treated With CDK 4/6 Inhibitors Are Excluded

 
• By Maureen Kenny

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.

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There was disagreement among EU regulators over what indication should be allowed • Source: Shutterstock

Piqray (alpelisib), Novartis’s new and much-touted medicine for the treatment of HR+/HER2- advanced breast cancer with a PIK3CA mutation, has been approved in Europe but its use has been restricted to an earlier setting than in markets such as the US where the potential blockbuster is already on the market and doing well commercially.

Whereas the wording of the proposed indication for Piqray in the EU covered patients previously treated with CDK 4/6 inhibitors, the authorized indication excludes those patients and is limited to...

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