Novartis: CHMP approves breast cancer drug

(CercleFinance.com) - Novartis has said that the CHMP of the European Medicines Agency has recommends the approval of its Piqray (alpelisib), in combination with fulvestrant for the treatment of HR+/HER2- advanced breast cancer with PIK3CA mutation.


This positive opinion concerns post-menopausal women and men affected by metastatic or locally advanced forms of this disease, and in the event of progression of the disease after endocrine therapy as monotherapy.

The Swiss pharmaceutical group explains that the opinion is based on a phase III trial that showed that this combination almost doubles progression-free survival (11 months against 5.7 months) in this patient population, compared to fulvestrant alone.


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