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AstraZeneca’s Faslodex gets US FDA nod in combination treatment for breast cancer

pharmafile | March 8, 2016 | News story | Manufacturing and Production, Research and Development AstraZeneca, Faslodex, US FDA, palbociclib 

UK drug-maker AstraZeneca said the US Food and Drug Administration (FDA) has approved a new indication expanding the use of its Faslodex (fulvestrant) to treat advanced or metastatic breast cancer.  

The drug will be used in combination with palbociclib. Faslodex was approved in 2002 as a monotherapy for the treatment of postmenopausal women with advanced or metastatic breast cancer whose cancer has progressed following antiestrogen therapy. 

Andrew Coop, vice president, US medical affairs, oncology at AstraZeneca, said, “We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments. This new indication adds to the existing body of evidence supporting Faslodex-based therapy for certain metastatic breast cancer patients in an area where there is still a high unmet medical need.” 

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Estrogen receptor positive breast cancer is the most common subtype of breast cancer. The US FDA approval of this new indication for Faslodex is based on data from the Phase III trial, which met the study’s primary endpoint of progression-free survival (PFS). The combination of Faslodex and palbociclib resulted in a 4.9 month progression free survival. 

Faslodex is indicated for the treatment of hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Anjali Shukla

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