FDA Grants Priority Review to Investigational Drug for a Subtype of Advanced or Metastatic Breast Cancer

The FDA’s decision to grant the investigational drug elacestrant a priority review for patients with ER-positive, HER2-negative advanced or metastatic breast cancer was based on data that showed the treatment bested standard-of-care in terms of improving survival.

The Food and Drug Administration (FDA) granted elacestrant, an investigational drug, a priority review for the treatment of patients with ER-positive, HER2-negative advanced or metastatic breast cancer, according to a press release.

The FDA grants priority reviews to investigational drugs that, if approved, may be a significant improvement over the standard-of-care therapy.

The decision was based off results from the phase 3 EMERALD trial. Here, treatment with the investigational drug elacestrant induced a 12-month progression-free survival (percentage of patients who did not have new tumor growth or cancer spread for a particular timeframe during or after treatment) rate of 22.32% versus 9.42% in the group who received standard-of-care single agent Faslodex (fulvestrant) or an aromatase inhibitor.

“We look forward to working with the FDA during its review of this submission, which addresses a new potential therapeutic option for a major unmet need in the management of patients with advanced or metastatic breast cancer after resistance builds in the earlier lines of the treatment,” Elcin Barker Ergun, CEO of the Menarini Group, the manufacturer of the investigational drug elacestrant, said in the press release.

The findings also showed that the use of elacestrant was associated with a significant 12-month progression-free survival benefit over standard-of-care Faslodex or an aromatase inhibitor in a group of patients with an ESR1 mutation (26.76% versus 8.19%).

Moreover, treatment with the investigational drug elacestrant reduced the risk for disease progression or death by 30% for the entire study population and 45% for patients with the ESR1 mutation.

In total, 477 patients who received prior treatment with either one or two lines of endocrine therapy were randomized to receive elacestrant or standard-of-care Faslodex or an aromatase inhibitor.

The release noted that previous preclinical studies showed that the investigational drug elacestrant proved efficacious as either a single agent or in combination with other therapies in breast cancer.

The FDA has set a date to decide on an approval of elacestrant by February 2023. However, the FDA is not bound by that date and can decide before or after that date.

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