Radius Health receives FDA fast track designation for elacestrant (RAD1901)

Radius Health

18 October 2017 - Radius plans to initiate Phase 2 clinical study of elacestrant as a third-line therapy for women with ER+ and HER2- breast cancer early in 2018.

Radius Health today announced that the U.S. FDA has granted fast track designation for elacestrant, an investigational oral selective estrogen receptor down-regulator/degrader (SERD) as a treatment of women with ER+ and HER2- advanced or metastatic breast cancer. Fast track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

The elacestrant clinical development program is currently ongoing with two Phase I studies in patients with ER+, HER2- advanced or metastatic breast cancer who have been heavily pre-treated (median of three prior lines of therapy) and have evaluable disease.

Read Radius Health press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track