Home » Menarini and Radius Receive FDA Priority Review of Elacestrant Drug
Menarini and Radius Receive FDA Priority Review of Elacestrant Drug
The FDA granted Menarini and Radius Health’s investigational drug elacestrant Priority Review for patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer.
In their New Drug Application, the companies are seeking approval of elacestrant as a second-line and a third-line therapy.
Under the Priority Review, the FDA will make a decision on the application within six months compared with the standard 10 months. The agency has set a decision date of Feb. 17, 2023.
The agency grants the priority designation to medicines that have the potential to provide significant improvements over current standard of care for serious conditions.
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