AstraZeneca’s Faslodex meets primary endpoint in breast cancer trial

The study compared Faslodex 500mg (fulvestrant) to Arimidex 1mg (anastrozole) to treat locally-advanced or metastatic breast cancer, in post-menopausal women who have not had prior hormonal treatment for hormone-receptor-positive breast cancer.

Faslodex 500mg was superior to Arimidex 1mg, and met its primary endpoint of extended progression-free survival.

The trial demonstrated an adverse event profile generally consistent with the existing knowledge of the medicines safety profile.

AstraZeneca is evaluating the data is ongoing and expects to present the results at a medical meeting later this year.

AstraZeneca executive vice president of global medicines development and chief medical officer Sean Bohen said: "The Falcon results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure.

"Faslodex has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio."

In an another development, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of AstraZeneca’s fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes (T2D).

The clinical data supporting the application demonstrated that the saxa/dapa combo with metformin statistically significantly reduced HbA1c levels compared to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy.

Another study showed that the saxa/dapa combo added to metformin produced superior reductions in HbA1c compared to dapagliflozin or saxagliptin alone added to metformin.