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FDA grants fast track designation to elacestrant for breast cancer subtype
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The FDA granted fast track designation to elacestrant for the treatment of ER-positive, HER-2-negative advanced or metastatic breast cancer, according to the drug’s manufacturer.
Elacestrant (RAD1901, Radius Health) an investigational oral selective ER downregulator/degrader is under investigation as a nonsteroidal treatment for hormone-driven or hormone-resistant breast cancer.
The clinical development program of elacestrant includes two phase 1 trials in patients ER-positive, HER-2-negative advanced or metastatic breast cancer who have been heavily pretreated and have evaluable disease.
“It is estimated that about one in eight women will develop invasive breast cancer over the course of their lifetime,” Jesper Høiland, president and CEO of Radius Health, said in a company-issued release. “If approved, elacestrant could offer a hormonal therapy alternative and potentially delay the use of chemotherapy in patients with ER-positive breast cancer. Early results of our phase 1 trial show an encouraging efficacy and safety profile. We look forward to working closely with the FDA as we rapidly advance the development of elacestrant.”