Novartis: advanced breast cancer drug gets FDA nod

(CercleFinance.com) - The US Food and Drug Administration has approved Novartis' Piqray, in combination with AstraZeneca's fulvestrant, for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer, the Swiss drugmaker said on Monday.


PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer, with approximately 40% of patients having this mutation.

FDA approval is based on results of a Phase III trial that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone.

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