AstraZeneca’s Faslodex recommended by CHMP for breast cancer approval

AstraZeneca's cancer therapy Faslodex has been recommended for European regulatory approval as part of a regimen for treating advanced breast cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending a new indication for the fulvestrant-based therapy that will allow it to be used as part of a combination therapy with palbociclib.

If approved by the European Commission, it will be made available for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.

This opinion was based on positive data from the phase III PALOMA-3 trial, which showed that this combination resulted in a 4.9-month progression-free survival  improvement compared to Faslodex alone, regardless of menopausal status.

Klaus Edvardsen, head of global oncology medicine development at AstraZeneca, said: "Fulvestrant-based treatment regimens may provide new options for patients with advanced breast cancer for whom there is still an unmet medical need."

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