FDA Approves Expanded Use of Fulvestrant as First-Line Hormonal Breast Cancer Therapy

AstraZeneca announced that the FDA has expanded the indications for fulvestrant (Faslodex). The drug is now approved as first-line monotherapy for women with certain types of breast cancer.

According to a press release from AstraZeneca, fulvestrant was approved as monotherapy for postmenopausal women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not previously received endocrine therapy.

The drug was first approved in 2002 for a narrower set of patients: postmenopausal women with HR+ metastatic breast cancer who did not respond to anti-estrogen therapy. In 2016, its indications were expanded as it was approved in combination with palbociclib in women with HR+, HER2- advanced or metastatic breast cancer whose cancer had progressed after endocrine therapy.

Results from the phase III FALCON trial provided the basis for the most recent indication, AstraZeneca stated. The clinical trial of 462 women observed a median progression-free survival of 16.6 months for the patients receiving fulvestrant, compared with 13.8 months for patients receiving anastrozole, an aromatase inhibitor used as the standard of care in HR+ advanced breast cancer. The improvement in survival with fulvestrant was equal to a 20% reduction in the risk of cancer progression or death.

After the FALCON results were published by The Lancet in November 2016, the European Commission expanded fulvestrant’s indications to include first-line monotherapy in July 2017. Its US counterpart, the FDA, followed suit less than a month later.

“This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey,” said Jamie Freedman, executive vice president, head of Oncology Business Unit at AstraZeneca, in the press statement announcing the FDA’s decision.

Fulvestrant is a type of hormonal therapy that blocks the estrogen receptors that play a role in the spread of HR+ metastatic breast cancer, thus slowing the cancer’s growth.

“This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required,” said Matthew Ellis, MD, PhD, in the press statement. Ellis, who is director of the Lester and Sue Smith Breast Center at Baylor College of Medicine, was a senior author of the November 2016 Lancet study detailing the FALCON trial findings.